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Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Sanofi
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01089569
First received: March 17, 2010
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Park Nicollet 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.



Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: May 2013
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 <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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089569

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
International Diabetes Center at Park Nicollet
Sanofi
Investigators
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

Publications:

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01089569     History of Changes
Other Study ID Numbers: 03951-10-C
Study First Received: March 17, 2010
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
diabetes
continuous glucose monitoring
exenatide
insulin glargine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013