Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
28. juli 2017 opdateret af: Pfizer
A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus
The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
84
Fase
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Chula Vista, California, Forenede Stater, 91911
- Profil Institute for Clinical Research, Inc.
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Florida
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Miami, Florida, Forenede Stater, 33169
- Elite Research Institute
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Miramar, Florida, Forenede Stater, 33025
- Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Atlanta Center for Medical Research
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68154
- ICON Clinical Pharmacology, LLC
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19139
- CRI Worldwide, LLC
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Texas
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San Antonio, Texas, Forenede Stater, 78209
- Healthcare Discoveries LLC d/b/a ICON Development Solutions
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- History of Type 2 diabetes and currently being treated with high dose metformin
- BMI between 22.0 and 40.0 kg/m2
- HbA1c between 7.0-10.0%
- Fasting C-peptide >1.21 ng/mL
Exclusion Criteria:
- History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
- Treatment with anti-diabetic therapies other than metformin
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
- Males or women of childbearing potential
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
13
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Placebo komparator: Treatment Arm 1 (Stage 1A)
|
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 2 (Stage 1A)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 3 (Stage 1A)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 4 (Stage 1A)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
|
Placebo komparator: Treatment Arm 5 (Stage 1B)
|
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 6 (Stage 1B)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 7 (Stage 1B)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 8 (Stage 1B)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
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Placebo komparator: Treatment Arm 9 (Stage 2)
|
Single subcutaneous injection of placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Andre navne:
|
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Eksperimentel: Treatment Arm 10 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 11 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
|
Eksperimentel: Treatment Arm 12 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
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Eksperimentel: Treatment Arm 13 (Stage 2)
|
Single subcutaneous injection of PF-04856883
Andre navne:
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Tidsramme: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Number of Participants With Clinically Significant Physical Examination Findings
Tidsramme: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
|
Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
Tidsramme: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
|
ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF).
ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec.
The number of participants with potentially clinically significant ECG findings at any visit were reported.
IFB = increase from baseline.
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Number of Participants With Vital Sign Abnormalities
Tidsramme: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
|
Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.
|
Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
|
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Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
Tidsramme: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
|
Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2*
ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR.
Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).
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Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
|
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
|
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
It is obtained from AUC (0 - t) plus AUC (t - ∞).
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
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Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22
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Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
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predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22
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Apparent Clearance (CL/F) of PF-04856883: Stage 1
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Outcome measure was planned to be analyzed in Stage 1 only.
|
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
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Apparent Clearance (CL/F) of PF-04856883: Stage 2
Tidsramme: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
|
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Outcome measure was planned to be analyzed in Stage 2 only.
Data was not estimable if values were below the limit of quantification.
|
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
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Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
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Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
Tidsramme: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
|
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
|
|
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Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
Tidsramme: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
|
|
|
Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Tidsramme: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
|
predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
|
|
|
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Tidsramme: Baseline, Day 3 and 8
|
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC
|
Baseline, Day 3 and 8
|
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Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Tidsramme: Baseline, Day 3, 15, 24, 29 and 50
|
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
|
Baseline, Day 3, 15, 24, 29 and 50
|
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Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Tidsramme: Baseline, Day 3 and 8
|
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
|
Baseline, Day 3 and 8
|
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Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Tidsramme: Baseline, Day 3, 15, 24, 29 and 50
|
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
|
Baseline, Day 3, 15, 24, 29 and 50
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Tidsramme: Baseline, Day 3 and 8
|
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
|
Baseline, Day 3 and 8
|
|
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Tidsramme: Baseline, Day 3, 15, 24, 29 and 50
|
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT.
Linear trapezoidal method was used to compute AUC.
|
Baseline, Day 3, 15, 24, 29 and 50
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Tidsramme: Baseline, Day 2, 4, 6, 15, 22 and 29
|
Baseline, Day 2, 4, 6, 15, 22 and 29
|
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Tidsramme: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
|
Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
|
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Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
Tidsramme: Baseline, Day 30
|
A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
|
Baseline, Day 30
|
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Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
Tidsramme: Baseline, Day 29 and 50
|
HbA1c is a measure of the glycosylated hemoglobin.
Change (measured as percent): HbA1c at observation minus HbA1c at baseline.
Outcome measure was planned to analyzed only for Stage 2.
|
Baseline, Day 29 and 50
|
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Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Tidsramme: Baseline, Day 8, 15 and 29
|
Baseline, Day 8, 15 and 29
|
|
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Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Tidsramme: Baseline, Day 8, 15, 22, 29 and 50
|
Baseline, Day 8, 15, 22, 29 and 50
|
|
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Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Tidsramme: Baseline, Day 8, 15 and 29
|
Baseline, Day 8, 15 and 29
|
|
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Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Tidsramme: Baseline, Day 8, 15, 22, 29 and 50
|
Baseline, Day 8, 15, 22, 29 and 50
|
|
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Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Tidsramme: Day 1 and 29
|
Day 1 and 29
|
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Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Tidsramme: Day 1, 29 and 50
|
Day 1, 29 and 50
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
1. marts 2011
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
1. december 2011
Studieafslutning (Faktiske)
Studieafslutning
1. april 2012
Datoer for studieregistrering
Først indsendt
Først indsendt
9. februar 2011
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
21. februar 2011
Først opslået (Skøn)
Først opslået
23. februar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
9. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2017
Sidst verificeret
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- B1111002
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .