Phase 3
N=461
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02229383 ↗Enrolled (actual)
461
Serious AEs
4.8%
Results posted
Sep 2017
Primary outcome: Primary: Change in HbA1c From Baseline to Week 28 — -0.96; -0.22 Percentage of HbA1c — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Exenatide (Drug); Exenatide matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 28 |
-0.96; -0.22 | <0.001 sig |
| SECONDARY Change in Body Weight From Baseline to Week 28 |
-1.04; 0.48 | <0.001 sig |
| SECONDARY Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT) |
-28.73; -0.96 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving HbA1c <7.0% at Week 28 |
32.6; 7.0 | <0.001 sig |
| SECONDARY Change From Baseline to Week 28 in Daily Insulin Dose |
1.6; 3.5 | 0.074 |
| SECONDARY Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks |
22.2; 2.2 | <0.001 sig |
| SECONDARY Change in Seated Systolic Blood Pressure From Baseline to Week 28 |
-2.5; -0.7 | 0.110 |
Summary
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.
Eligibility Criteria
Inclusion criteria
- Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
- Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
- Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:
- a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
- a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit
Exclusion criteria
- Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
- History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
- Positive serological test for hepatitis B or hepatitis C
Data sourced from ClinicalTrials.gov (NCT02229383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.