Phase 3
Completed N=303
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
Source: ClinicalTrials.gov NCT00308139 ↗Enrolled (actual)
303
Serious AEs
18.0%
Results posted
Aug 2012
Primary outcomePrimary: Change in HbA1c From Baseline to Week 30 — -1.87; -1.54 percentage of total hemoglobin — p=0.0023
Summary
A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 30 |
-1.87; -1.54 | 0.0023 sig |
| PRIMARY Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose) |
— | — |
| SECONDARY Change in HbA1c From Baseline to Week 364 |
-1.49; -1.57; -1.53 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of <7% |
41.4; 50.0; 45.9 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of <7% |
41.4; 50.0; 45.9 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of <=6.5% |
22.4; 37.5; 30.3 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of <=6.5% |
22.4; 37.5; 30.3 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of <=6.0% |
23.0; 16.3 | 0.1513 |
| SECONDARY Exenatide LAR Steady State Concentration From Week 29 to Week 30 |
300.23 | — |
| SECONDARY Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14 |
-95.88; -125.96 | 0.0124 sig |
| SECONDARY Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose) |
— | — |
| SECONDARY Change in Body Weight From Baseline to Week 30 |
-3.67; -3.59 | 0.8916 |
| SECONDARY Change in Body Weight From Baseline to Week 364 |
-5.25; -2.71; -3.87 | — |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Week 30 |
-41.5; -24.6 | <.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Week 364 |
-18.3; -27.7; -23.6 | — |
| SECONDARY Change in Blood Pressure From Baseline to Week 30 |
-4.4; -3.8; -1.1; -2.3 | — |
| SECONDARY Change in Blood Pressure From Baseline to Week 364 |
1.3; 1.0; 1.2; -1.7; -3.6; -2.7 | — |
| SECONDARY Change in Total Cholesterol From Baseline to Week 30 |
-11.9; -3.8 | 0.0077 sig |
| SECONDARY Change in Total Cholesterol From Baseline to Week 364 |
-15.0; -4.8; -9.6 | — |
| SECONDARY Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30 |
-0.9; -1.3 | 0.5613 |
| SECONDARY Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364 |
2.2; 3.4; 2.8 | — |
| SECONDARY Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364 |
-13.6; -7.5; -10.4 | — |
| SECONDARY Ratio of Triglycerides at Week 30 to Baseline |
0.85; 0.89 | 0.2915 |
| SECONDARY Ratio of Triglycerides at Week 364 to Baseline |
0.91; 0.94; 0.93 | — |
| SECONDARY Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening |
0.00; 0.00; 0.00; 0.00; 0.00; 0.57 | — |
| SECONDARY Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
- Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
- Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
- (For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105
Exclusion Criteria
- Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
- Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
- Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
- Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
- Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
- Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
- Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
- Regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
- Prescription or over-the-counter weight loss medications within 6 months of screening.
- (For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy
Data sourced from ClinicalTrials.gov (NCT00308139). 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. Informational only — not medical advice.