A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus (EGO)
8. desember 2014 oppdatert av: Eli Lilly and Company
The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus
To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
262
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arizona
-
Peoria, Arizona, Forente stater, 85381
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
California
-
Anaheim, California, Forente stater, 92805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Lancaster, California, Forente stater, 93534
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Northridge, California, Forente stater, 91326
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Palm Springs, California, Forente stater, 92262
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Florida
-
South Miami, Florida, Forente stater, 33143
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
West Palm Beach, Florida, Forente stater, 33401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Georgia
-
Athens, Georgia, Forente stater, 30606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Atlanta, Georgia, Forente stater, 30303
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Illinois
-
Springfield, Illinois, Forente stater, 62704
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46250
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Maine
-
Biddeford, Maine, Forente stater, 04005
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48108
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Bloomfield Hills, Michigan, Forente stater, 48302
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63141
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Montana
-
Billings, Montana, Forente stater, 59101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New Jersey
-
Flemington, New Jersey, Forente stater, 08822
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New York
-
Syracuse, New York, Forente stater, 13210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
North Carolina
-
Greensboro, North Carolina, Forente stater, 27401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Greenville, North Carolina, Forente stater, 27834
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Morehead City, North Carolina, Forente stater, 28557
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Tennessee
-
Memphis, Tennessee, Forente stater, 38119
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Texas
-
Austin, Texas, Forente stater, 78731
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Dallas, Texas, Forente stater, 75230
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
San Antonio, Texas, Forente stater, 78237
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Virginia
-
Norfolk, Virginia, Forente stater, 23510
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Washington
-
Renton, Washington, Forente stater, 98057
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Spokane, Washington, Forente stater, 99216
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tacoma, Washington, Forente stater, 98405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Wenatchee, Washington, Forente stater, 98801
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Wisconsin
-
Menomonee Falls, Wisconsin, Forente stater, 53051
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
-
-
-
Manatí, Puerto Rico, 00674
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
San Juan, Puerto Rico, 00907
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Toa Baja, Puerto Rico, 00949
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Type 2 Diabetes Mellitus >3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007).
- Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
- Have glycosylated hemoglobin (HbA1c) of >7.0% to ≤10.5% as determined by central laboratory at screening.
- Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m^2), inclusive.
- Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).
Exclusion Criteria:
- Have known Type 1 Diabetes Mellitus
- Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)
- Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty [PTCA], open heart surgery, or coronary artery bypass graft [CABG]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
- Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) >2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.
- Currently taking prescription or over the counter medications to prevent weight loss.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1.0/2.0 milligram (mg) LY2189265
LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
|
Andre navn:
|
|
Eksperimentell: 1.0/1.0 milligram (mg) LY2189265
LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks
|
Andre navn:
|
|
Eksperimentell: 0.5/1.0 milligram (mg) LY2189265
LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
|
Andre navn:
|
|
Placebo komparator: Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Tidsramme: Baseline, 16 weeks
|
Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).
|
Baseline, 16 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
Tidsramme: Baseline, 16 weeks
|
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast.
Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
|
Baseline, 16 weeks
|
|
Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)
Tidsramme: Baseline and 16 weeks
|
Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination.
Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test.
A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes.
Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal.
Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.
|
Baseline and 16 weeks
|
|
Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles
Tidsramme: 2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.
|
Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am.
The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day.
Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
|
2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.
|
|
Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)
Tidsramme: Baseline, 16 weeks
|
Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations.
A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.
|
Baseline, 16 weeks
|
|
Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%
Tidsramme: Baseline and 4 and 8 and 16 weeks
|
Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.
|
Baseline and 4 and 8 and 16 weeks
|
|
Change From Baseline in Body Weight
Tidsramme: Baseline, 4, 8, and 16 weeks
|
LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
|
Baseline, 4, 8, and 16 weeks
|
|
Change From Baseline in Waist Circumference
Tidsramme: Baseline, 16 weeks
|
Mean change from baseline in waist circumference (a measure of central obesity).
|
Baseline, 16 weeks
|
|
Nausea and Dyspepsia Measured by Visual Analog Scale
Tidsramme: One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits
|
Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.
|
One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits
|
|
Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores
Tidsramme: Baseline and 4 and 8 and 16 weeks
|
Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit.
GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.
|
Baseline and 4 and 8 and 16 weeks
|
|
Number of Participants With a Hypoglycemic Event
Tidsramme: Baseline through 4, 8, and 16 weeks
|
A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment.
A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL.
Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 4, 8, and 16 weeks
|
|
Rate of Hypoglycemia Per 30 Days
Tidsramme: Baseline through 16 weeks
|
Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment.
The rate is the average number of days out of 30 that a participant reported hypoglycemia.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 16 weeks
|
|
Change From Baseline in Lipids
Tidsramme: Baseline, 16 weeks
|
Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.
|
Baseline, 16 weeks
|
|
Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
Tidsramme: Baseline and 4 and 8 and 16 weeks
|
The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6-point scale ranging from 1 "completely dissatisfied" to 6 "completely satisfied"; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time"; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time."
These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale.
The percentage of participants that rated their general health as good or better are summarized.
|
Baseline and 4 and 8 and 16 weeks
|
|
Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
Tidsramme: Baseline and 4 and 8 and 16 weeks
|
This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use.
Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected.
A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation.
Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.
|
Baseline and 4 and 8 and 16 weeks
|
|
Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)
Tidsramme: Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks
|
The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).
|
Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2008
Primær fullføring (Faktiske)
1. januar 2009
Studiet fullført (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først innsendt
28. februar 2008
Først innsendt som oppfylte QC-kriteriene
28. februar 2008
Først lagt ut (Anslag)
7. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12068 (Annen identifikator: DAIDS)
- H9X-MC-GBCJ (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .