A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
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:
NCT00960661
First received: August 17, 2009
Last updated: January 31, 2013
Last verified: October 2012
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Purpose
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: exenatide Drug: insulin lispro |
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: | A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Insulin human
Insulin lispro
Exenatide
Insulin glargine
U.S. FDA Resources
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- To estimate the difference in change in HbA1c between 2 regimens: BET (basal insulin Glargine, Exenatide BID and metformin) and BBT (basal insulin Glargine, bolus insulin insulin TID and metformin). [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the efficacy and safety between the BET and BBT regimens with respect to percentage of subjects with HbA1C ≤ 7.0% with minimum weight gain and with HbA1C ≤ 6.5% with minimum weight gain (≤ 1 kg). [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to percent of subjects with HbA1c ≤ 7.0% and ≤ 6.5%. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to fasting blood glucose (FBG). [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to 7-point self-monitored blood glucose (SMBG) profiles and daily mean blood glucose (BG) based on the 7-point SMBG profile. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to fasting glucagon. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to body weight and BMI. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to waist and hip circumference (cm). [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to insulin dose (24-hour total international units [IU] and total units/kg body weight). [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to seated systolic (SBP) and diastolic blood pressure (DBP). [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
- To compare the efficacy and safety between the BET and BBT regimens with respect to various measures of safety. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1036 |
| Study Start Date: | September 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: exenatide
subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
Other Name: Byetta
|
| Active Comparator: 2 |
Drug: insulin lispro
titrated based on pre-meal glucose level; three times a day
Other Name: Humalog
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
- Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
- Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
- Have an HbA1C > 7.0% and ≤ 10.0%.
- Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.
Exclusion Criteria:
- Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
- Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
- Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have previously completed or been withdrawn from this study after enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960661
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| Buenos Aires, Argentina | |
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| Caba, Argentina | |
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| Capital Federal, Argentina | |
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| Ciudad Autonoma de Buenos Aire, Argentina | |
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| Ciudad de Buenos Aires, Argentina | |
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| Penarth, United Kingdom | |
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| Wakefield, United Kingdom | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | Chief Medical Officer, MD | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00960661 History of Changes |
| Other Study ID Numbers: | H8O-EW-GWDM |
| Study First Received: | August 17, 2009 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Italy: The Italian Medicines Agency Netherlands: Medicines Evaluation Board (MEB) Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Finland: Finnish Medicines Agency Estonia: Ravimiamet, Estonian State Agency of Medicines Korea: Korea Food and Drug Administration Russia: Ministry of Health of Russian Federation Argentina: ANMAT (Administración Nacional de Medicamentos, Alimentos, y Tecnología Médica) Mexico: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
diabetes exenatide Byetta insulin lispro Humalog |
insulin glargine Lantus Amylin Lilly |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Insulin LISPRO |
Glargine Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013