Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

HealthPartners Institute

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin Glargine; Drug: Exenatide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01089569

03951-10-C

Details and patient eligibility

About

The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

Full description

The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.

An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects ≥18 and ≤75 years of age
• Clinical diagnosis of type 2 diabetes
• Diabetes duration ≥ 1 year
• HbA1c ≥7.0%
• Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)

Exclusion criteria

• Previously treated with insulin or incretin-based therapy
• Treated with a thiazolidinedione within past 6 weeks
• Taken oral or injected prednisone or cortisone medications in the previous 30 days
• Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
• Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
• eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
• ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)
• Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
• Currently pregnant or planning pregnancy during the study period
• Unable to follow the study protocol
• Unable to speak, read and write in English
• Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
• At the investigator's discretion for other medical or psychological reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Exenatide

Active Comparator group

Description:

5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

Treatment:

Drug: Exenatide

Insulin Glargine

Active Comparator group

Description:

.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Treatment:

Drug: Insulin Glargine

Exenatide + Insulin Glargine

Active Comparator group

Description:

Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study + Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Treatment:

Drug: Exenatide

Drug: Insulin Glargine