Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

This study has been completed.
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: October 9, 2013
Last verified: October 2013

March 17, 2010
October 9, 2013
April 2010
May 2013   (final data collection date for primary outcome measure)
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)

Same as current
Complete list of historical versions of study NCT01089569 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Exenatide
    refer to Arm detail
  • Drug: Insulin Glargine
    refer to Arm detail
  • Active Comparator: Exenatide
    5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
    Intervention: Drug: Exenatide
  • Active Comparator: Insulin Glargine
    .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
    Intervention: Drug: Insulin Glargine
  • Active Comparator: Exenatide + Insulin Glargine
    Interventions:
    • Drug: Exenatide
    • Drug: Insulin Glargine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01089569
03951-10-C
No
Park Nicollet Institute
Park Nicollet Institute
  • International Diabetes Center at Park Nicollet
  • Sanofi
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
Park Nicollet Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP