A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00360334
First received: August 2, 2006
Last updated: May 13, 2013
Last verified: February 2013
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Composite endpoint evaluating effect of treatment on glycemic control and weight
Secondary Outcome Measures:
- Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Composite endpoint evaluating effect of treatment on glycemic control and weight
- Change in Fasting Serum Glucose [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
- Percent of Patients Achieving HbA1c ≤ 7.4% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of patients achieving specified HbA1c target at endpoint
- Percent of Patients Achieving HbA1c < 7% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of patients achieving specified HbA1c target at endpoint
- Percent of Patients Achieving HbA1c < 6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of patients achieving specified HbA1c target at endpoint
- Change in 7 Point Self Monitored Blood Glucose Profile [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
- Change in Body Mass Index (BMI) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in BMI from baseline to endpoint
- Change in Waist Circumference [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]Change in waist circumference from baseline to endpoint
- Change in Waist-to-hip Ratio [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in waist-to-hip ratio from baseline to endpoint
- Change in Body Weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in body weight from baseline to endpoint
- Percent Change in Body Weight [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]Percent change in baseline body weight at endpoint
- Percent of Patients Achieving 5% Weight Loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of patients who lost at least 5% of baseline body weight at endpoint
- Percent of Patients Achieving 10% Weight Loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of patients who lost at least 10% of baseline body weight at endpoint
- Change in Systolic Blood Pressure [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in systolic blood pressure from baseline to endpoint
- Change in Diastolic Blood Pressure [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in diastolic blood pressure from baseline to endpoint
- Change in Fasting Serum Total Cholesterol (TC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in TC from baseline to endpoint
- Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in HDL cholesterol from baseline to endpoint
- Change in TC to HDL Cholesterol Ratio [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in TC to HDL cholesterol ratio from baseline to endpoint
- Change in Fasting Serum Triglycerides [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in fasting serum triglycerides from baseline to endpoint
- Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in LDL cholesterol from baseline to endpoint
- Change in Apolipoprotein-B [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Change in apolipoprotein-B from baseline to endpoint
- Incidence of Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
- Incidence of Nocturnal Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
- Incidence of Severe Hypoglycemic Episodes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
- Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Number of hypoglycemic episodes per patient adjusted per 30 days
- Nocturnal Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days
- Severe Hypoglycemic Rate Per 30 Days [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Number of severe hypoglycemic episodes per patient adjusted per 30 days
| Enrollment: | 235 |
| 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 |
|---|---|
| Experimental: 1 |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Name: Byetta
|
| Active Comparator: 2 |
Drug: insulin glargine
subcutaneous injection, titrated to target blood glucose level, once a day
Other Name: Lantus
|
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 glucagon-like peptide-1 (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 | |
| Aberdeen, United Kingdom | |
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| Bath, United Kingdom | |
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| Blackburn, United Kingdom | |
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| Bolton, United Kingdom | |
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| Bournemouth, United Kingdom | |
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| Bristol, United Kingdom | |
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| Chippenham, United Kingdom | |
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| Edinburgh, United Kingdom | |
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| Glasgow, United Kingdom | |
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| Haywards Heath, United Kingdom | |
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| High Wycombe, United Kingdom | |
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| Hull, United Kingdom | |
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| Ipswich, United Kingdom | |
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| Kent, United Kingdom | |
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| Leicester, United Kingdom | |
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| Liverpool, United Kingdom | |
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| Livingstone, United Kingdom | |
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| London, United Kingdom | |
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| Manchester, United Kingdom | |
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| Middlesborough, United Kingdom | |
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| Norwich, United Kingdom | |
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| Nottingham, United Kingdom | |
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| Oldham, United Kingdom | |
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| Oxford, United Kingdom | |
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| Plymouth, United Kingdom | |
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| Rochdale, United Kingdom | |
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| Salford, United Kingdom | |
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| Swansea, United Kingdom | |
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| Torquay, United Kingdom | |
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| Wakefield, United Kingdom | |
| Research Site | |
| Wirral, United Kingdom | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | Mauricio Silva de Lima, MD | Eli Lilly and Company |
More Information
No publications provided by Amylin Pharmaceuticals, LLC.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00360334 History of Changes |
| Other Study ID Numbers: | H8O-BP-GWBG |
| Study First Received: | August 2, 2006 |
| Results First Received: | April 14, 2009 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
diabetes exenatide insulin glargine Lilly Amylin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Weight Gain Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Body Weight Changes Body Weight |
Signs and Symptoms Exenatide Glargine Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013