Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exenatide Twice Daily (BID)

Group Type EXPERIMENTAL

exenatide twice daily (BID)

Intervention Type DRUG

subcutaneous injection (5 mcg or 10 mcg), twice a day

Premixed Insulin Aspart Twice Daily (BID)

Group Type ACTIVE_COMPARATOR

premixed insulin aspart twice daily (BID)

Intervention Type DRUG

subcutaneous injection (titrated appropriately), twice a day

Interventions

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exenatide twice daily (BID)

subcutaneous injection (5 mcg or 10 mcg), twice a day

Intervention Type DRUG

premixed insulin aspart twice daily (BID)

subcutaneous injection (titrated appropriately), twice a day

Intervention Type DRUG

Other Intervention Names

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Byetta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No