A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Collaborator:	Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00360334

Purpose

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: exenatide Drug: insulin glargine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Exenatide Insulin glargine

U.S. FDA Resources

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

Primary Outcome Measures:

Proportion of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Fasting Serum Glucose [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Proportion of Patients Achieving HbA1c ≤ 7.4% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Proportion of Patients Achieving HbA1c < 7% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Proportion of Patients Achieving HbA1c < 6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in 7 Point Self Monitored Blood Glucose Profile [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Body Mass Index (BMI) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Waist Circumference [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Change in Waist-to-Hip Ratio [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Body Weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Percent Change in Body Weight [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Proportion of Patients Achieving 5% Weight Loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Proportion of Patients Achieving 10% Weight Loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Systolic Blood Pressure [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Diastolic Blood Pressure [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Fasting Serum Total Cholesterol (TC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in TC to HDL Cholesterol Ratio [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Fasting Serum Triglycerides [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in Apolipoprotein-B [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Incidence of Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Incidence of Nocturnal Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Incidence of Severe Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Nocturnal Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Severe Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment:	234
Study Start Date:	June 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day
2: Active Comparator	Drug: insulin glargine subcutaneous injection, titrated to target blood glucose level, once a day

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with type 2 diabetes
Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
HbA1c between 7.5% and 10.0%.
BMI >27.

Exclusion Criteria:

Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or GLP-1 analogue; *Anti-obesity agent use within the last 3 months.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360334

Locations

United Kingdom
Research Site
London, United Kingdom
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Torquay, United Kingdom
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Wakefield, United Kingdom
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Swansea, United Kingdom
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Oldham, United Kingdom
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Nottingham, United Kingdom
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High Wycombe, United Kingdom
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Liverpool, United Kingdom
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Glasgow, United Kingdom
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Bournemouth, United Kingdom
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Hull, United Kingdom
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Kent, United Kingdom
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Norwich, United Kingdom
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Aberdeen, United Kingdom
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Ipswich, United Kingdom
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Rochdale, United Kingdom
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Edinburgh, United Kingdom
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Leicester, United Kingdom
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Salford, United Kingdom
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Bristol, United Kingdom
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Plymouth, United Kingdom
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Livingstone, United Kingdom
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Middlesborough, United Kingdom
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Blackburn, United Kingdom
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Wirral, United Kingdom
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Haywards Heath, United Kingdom
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Manchester, United Kingdom
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Oxford, United Kingdom
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Bath, United Kingdom
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Chippenham, United Kingdom
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Bolton, United Kingdom

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

Mauricio Silva de Lima, MD

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company ( Chief Medical Officer )
Study ID Numbers:	H8O-BP-GWBG
Study First Received:	August 2, 2006
Results First Received:	April 14, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00360334 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide
insulin glargine
Lilly
Amylin

Additional relevant MeSH terms:

Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Weight Gain
Pharmacologic Actions
Insulin

Body Weight
Signs and Symptoms
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Body Weight Changes
Glargine
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 09, 2010