Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

NCT01089569 | Completed Results

• 1 other identifier: 03951-10-C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; continuous glucose monitoring; exenatide; insulin glargine

Outcome Measures

Primary Outcomes (1)

• HbA1c Change

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

  baseline to final visit (32 weeks)

Secondary Outcomes (6)

• Change From Baseline in Incidence of Hypoglycemia (Frequency)

  baseline to final visit (32 weeks)

• Change From Baseline in Incidence of Hypoglycemia (Degree)

  baseline to final visit (32 weeks)

• Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)

  baseline to final visit (32 weeks)

• Change From Baseline in CGM Glucose Variability

  baseline to final visit (32 weeks)

• Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)

  baseline - final visit (32 weeks)

Study Arms (3)

Exenatide

ACTIVE COMPARATOR

5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

Drug: Exenatide

Insulin Glargine

ACTIVE COMPARATOR

.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Drug: Insulin Glargine

Exenatide + Insulin Glargine

ACTIVE COMPARATOR

Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study \+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Drug: Exenatide; Drug: Insulin Glargine

Interventions

Exenatide DRUG

5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

Also known as: Bydureon

Exenatide; Exenatide + Insulin Glargine

Insulin Glargine DRUG

.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Also known as: Lantus

Exenatide + Insulin Glargine; Insulin Glargine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• International Diabetes Center at Park Nicollet: collaborator
• Sanofi: collaborator

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (2)

• 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.

  PMID: 18473688 BACKGROUND

• 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.

  PMID: 19454385 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Richard M. Bergenstal
• Organization: International Diabetes Center

richard.bergenstal@parknicollet.com

952-993-1913

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects were randomized and then told the medications they were randomized to. Since the medications were already on the market, there was no need for masking for any involved individuals.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2013-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)