Phase 3
N=494
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00434954 ↗Enrolled (actual)
494
Serious AEs
3.5%
Results posted
Aug 2010
Primary outcome: Primary: Change in Glycosylated Hemoglobin (HbA1c) — -1.00; -1.14 Percentage of glycosylated hemoglobin — p=0.055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- exenatide twice daily (BID) (Drug); premixed insulin aspart twice daily (BID) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Hemoglobin (HbA1c) |
-1.00; -1.14 | 0.055 |
| PRIMARY Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode) |
8.0; 20.5 | <0.05 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of < 6.5% |
27.6; 24.9 | 0.554 |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of < 7.0% |
49.2; 56.6 | 0.159 |
| SECONDARY Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period) |
1.8; 6.3 | — |
| SECONDARY Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period) |
3.9; 7.0 | — |
| SECONDARY 7 Point Self-monitored Blood Glucose (SMBG) Profiles |
8.933; 9.005; 7.774; 7.293; 10.821; 10.902 | — |
| SECONDARY Blood Lipid Levels |
5.147; 5.084; 4.971; 5.050; 1.234; 1.255 | — |
| SECONDARY Change in Body Weight |
-4.10; 1.02 | <0.0001 sig |
| SECONDARY Change in Body Mass Index (BMI) |
-1.39; 0.32 | <0.0001 sig |
| SECONDARY Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
29.5; 29.7; 30.6; 29.3 | — |
| SECONDARY Patient Reported Outcomes: Quality of Life (SF-12) |
35.5; 36.3; 39.1; 37.7; 31.3; 28.3 | — |
Summary
This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
Eligibility Criteria
Inclusion Criteria
- Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
- Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
- Have an HbA1c between 6.5% and 10.0%, inclusive
- Have a body mass index (BMI) between 25 kg/m^2 and 40 kg/m^2, inclusive
Exclusion Criteria
- Have type 1 diabetes or known latent autoimmune diabetes in adults
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
- Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
- Have used any prescription drug to promote weight loss within 3 months prior to study start
- Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
- Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs
Data sourced from ClinicalTrials.gov (NCT00434954). 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.