Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

This study has been completed.
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
HealthPartners Institute Identifier:
First received: March 17, 2010
Last updated: October 9, 2013
Last verified: October 2013
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.

Condition Intervention
Type 2 Diabetes
Drug: Exenatide
Drug: Insulin Glargine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis

Resource links provided by NLM:

Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Continuous Glucose Monitoring [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

    Employ CGM with AGP analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.

    Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) ii. Glucose variability (inter-quartile range) iii. Glucose stability (hourly change in the median curve iv. Incidence of hypoglycemia (degree, duration, frequency)

Secondary Outcome Measures:
  • Continuous Glucose Monitoring and Lab Tests [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

    Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination Measure the changes in weight attributable to exenatide, insulin glargine and their combinations.

    Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exenatide
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
Drug: Exenatide
refer to Arm detail
Active Comparator: Insulin Glargine
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Drug: Insulin Glargine
refer to Arm detail
Active Comparator: Exenatide + Insulin Glargine Drug: Exenatide
refer to Arm detail
Drug: Insulin Glargine
refer to Arm detail


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 <30 ml/min (using MDRD equation
  • ALT>2xULN
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01089569

United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
International Diabetes Center at Park Nicollet
Principal Investigator: Richard M Bergenstal, MD International Diabetes Center at Park Nicollet
Principal Investigator: Roger S Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Elinor S Strock, APRN International Diabetes Center at Park Nicollet
  More Information

Responsible Party: HealthPartners Institute Identifier: NCT01089569     History of Changes
Other Study ID Numbers: 03951-10-C
Study First Received: March 17, 2010
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by HealthPartners Institute:
continuous glucose monitoring
insulin glargine

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin, Long-Acting
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015