Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

NCT ID: NCT01089569

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-05-31

Brief Summary

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.

Detailed 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exenatide

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

Group Type: ACTIVE_COMPARATOR

Exenatide

Intervention Type: DRUG

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

Insulin Glargine

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

Group Type: ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type: DRUG

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

Exenatide + Insulin Glargine

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

Group Type: ACTIVE_COMPARATOR

Exenatide

Intervention Type: DRUG

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

Insulin Glargine

Intervention Type: DRUG

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

Interventions

Exenatide

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

Intervention Type: DRUG

Insulin Glargine

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

Intervention Type: DRUG

Other Intervention Names

Bydureon; Lantus

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Diabetes Center at Park Nicollet

OTHER

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard M Bergenstal, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Roger S Mazze, PhD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Elinor S Strock, APRN

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Locations

International Diabetes Center

Minneapolis, Minnesota, United States

Countries

United States

References

Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293.

Reference Type: BACKGROUND

PMID: 18473688 (View on PubMed)

Mazze R, Strock E, Morgan B, Wesley D, Bergenstal R, Cuddihy R. Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profile analysis. Endocr Pract. 2009 May-Jun;15(4):326-34. doi: 10.4158/EP09046.ORR.

Reference Type: BACKGROUND

PMID: 19454385 (View on PubMed)

Other Identifiers

03951-10-C

Identifier Type: -

Identifier Source: org_study_id