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 - Full Text View

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:

MedlinePlus related topics: Compulsive Gambling Diabetes Diabetes Medicines Diabetes Type 2

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

Show 97 Study Locations

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 June 17, 2013