Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

Type 2 Diabetes Clinical Trial

Official title:

Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089569
• Other study ID #: 03951-10-C
• Status: Completed
• Phase: N/A
• First received: March 17, 2010
• Last updated: November 30, 2015
• Start date: April 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Exenatide
refer to Arm detail
• Insulin Glargine
refer to Arm detail

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	International Diabetes Center at Park Nicollet, Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Glucose Monitoring	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)	40 weeks	No
Secondary	Continuous Glucose Monitoring and Lab Tests	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.	40 weeks	No