Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM
12 november 2018 uppdaterad av: Xuefeng Yu, Huazhong University of Science and Technology
Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Switching Premix Human Insulin to Aspart30 in T2DM With Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel Trial
Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel trial.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a multicentre, open-label, randomized and parallel trial that will compare the efficacy and safety of basal insulin glargine combination with Exenatide bid vs. switching premix human insulin to aspart30 in type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin. Approximately 248 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 + metformin.
Study treatment will continue for 24 weeks. The primary efficacy measure is the change in HbA1c at 24 weeks. The study consists of 3 periods: a 1-week screening (period A), a 12-week run-in period (period B) and a 24-week treatment period (period C).
Studietyp
Interventionell
Inskrivning (Faktisk)
349
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Hubei
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Wuhan, Hubei, Kina, 430000
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Provision of informed consent
- Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 U/d and metformin with maximum tolerated dosage (≤ 1500mg/d)
- HbA1c > 8.0 % and < 11.0 % (HbA1c > 7.0 % and < 10.0% at randomization)
- Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
- BMI ≥ 23 and ≤ 35 kg/m2
Exclusion Criteria:
- Type 1 diabetes or other specific types of diabetes
- Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
- Uncooperative subject because of various reasons
- Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal
- Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male
- Serious chronic gastrointestinal diseases
- Edema
- Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
- Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
- White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L，or definite anemia (Hb：< 120g/L for male, < 110g/L for female), or other hematological diseases
- Endocrine system diseases, such as hyperthyroidism and hypercortisolism
- Experimental drug allergy or frequent hypoglycemia
- Psychiatric disorders, drug or other substance abuse
- Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
- Stressful situations such as surgery, serious trauma and so on
- Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
- Combined use of drugs effecting glucose metabolism such as glucocorticoid
- Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: glargine + exenatide
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously.
After a 12-week run-in period , switching premix human insulin to glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily).
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glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)
|
|
Aktiv komparator: aspart 30
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously.
After a 12-week run-in period , switching premix human insulin to aspart 30 ( subcutaneous injection, twice daily).
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aspart 30 ( subcutaneous injection, twice daily)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.
Tidsram: from baseline to 24-week endpoint
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from baseline to 24-week endpoint
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in HbA1c from baseline to 12 weeks endpoint
Tidsram: from baseline to 12 weeks endpoint
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from baseline to 12 weeks endpoint
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The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
Tidsram: 12 weeks and 24 weeks
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12 weeks and 24 weeks
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Fasting blood glucose
Tidsram: 12 weeks and 24 weeks
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12 weeks and 24 weeks
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Daily insulin use
Tidsram: baseline, 12 weeks and 24 weeks
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baseline, 12 weeks and 24 weeks
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Change in body weight
Tidsram: from baseline to 12 and 24 weeks
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from baseline to 12 and 24 weeks
|
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The incidence and rate of hypoglycaemic events during the study
Tidsram: baseline, 12 weeks and 24 weeks
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baseline, 12 weeks and 24 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2015
Primärt slutförande (Faktisk)
1 december 2017
Avslutad studie (Faktisk)
1 december 2017
Studieregistreringsdatum
Först inskickad
2 juni 2015
Först inskickad som uppfyllde QC-kriterierna
5 juni 2015
Första postat (Uppskatta)
10 juni 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 november 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 november 2018
Senast verifierad
1 november 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ESR-14-10352
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