Clinical trial NCT01089569: Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Official title: Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
continuous glucose monitoring
exenatide
insulin glargine
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Sanofi
First posted: 2010-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HbA1c Change
timeFrame: baseline to final visit (32 weeks)
Secondary outcomes:
measure: Change From Baseline in Incidence of Hypoglycemia (Frequency)
timeFrame: baseline to final visit (32 weeks)
measure: Change From Baseline in Incidence of Hypoglycemia (Degree)
timeFrame: baseline to final visit (32 weeks)
measure: Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)
timeFrame: baseline to final visit (32 weeks)
measure: Change From Baseline in CGM Glucose Variability
timeFrame: baseline to final visit (32 weeks)
measure: Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)
timeFrame: baseline - final visit (32 weeks)
measure: Change From Baseline in Weight Changes
timeFrame: baseline - final visit (32 weeks)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Richard M Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Roger S Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Elinor S Strock, APRN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.