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

Sponsor:	Amylin Pharmaceuticals, Inc.
Collaborator:	Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00434954

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide Drug: insulin aspart	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin aspart Exenatide Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

To test the hypothesis that exenatide is non-inferior to premixed human insulin aspart in terms of glycemic control, and superior to premixed human insulin aspart in terms of hypoglycemia incidence, when given in combination with metformin. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the two injectable treatment regimens with respect to: [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>proportion of patients achieving pre-specified HbA1c targets [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>percentage of patients with at least one treatment-emergent hypoglycemic episode [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>nocturnal hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>blood glucose control [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>blood lipid levels [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>anthropometric measures [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>patient reported outcomes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	488
Study Start Date:	February 2007
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Drug: exenatide subcutaneous injection (5 mcg or 10 mcg), twice a day
Group B: Active Comparator	Drug: insulin aspart subcutaneous injection (titrated appropriately), twice a day

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434954

Locations

Germany
Research Site
Leipzig, Germany
Research Site
Schwedt/Oder, Germany
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Unterhaching, Germany
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Bosenheim, Germany
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Hirschhorn, Germany
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Warburg, Germany
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Jena, Germany
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Friedrichsthal, Germany
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Essen, Germany
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Wangen, Germany
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Mannheim, Germany
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Hildesheim, Germany
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Lehrte, Germany
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Berlin, Germany
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Wallerfing, Germany
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Volklingen, Germany
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Roding, Germany
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Munchen, Germany
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Regensburg, Germany
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Marktheidenfeld, Germany
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Riesa, Germany
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Meissen, Germany
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Rosenheim, Germany
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Rodgau, Germany
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Hohenmolsen, Germany
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Pohlheim, Germany
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Speyer, Germany
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Schluchtern, Germany
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Oschatz, Germany
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Ludwigsburg, Germany
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Bad Mergentheim, Germany
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Wiesbaden, Germany
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Offenbach, Germany
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Wolfsburg, Germany
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Burghausen, Germany
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Dresden, Germany
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Marburg, Germany
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Sinsheim, Germany
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Datteln, Germany

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-SB-GWBN
Study First Received:	February 12, 2007
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00434954 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide
Byetta
Amylin
Lilly

Additional relevant MeSH terms:

Metabolic Diseases
Exenatide
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Hypoglycemia

Insulin
Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009