Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

NCT00765817 | Completed Phase 3 Results

• 1 other identifier: H8O-US-GWCO
• Study Type: interventional
• Target: 261
• Locations: 6 countries
• Sites: 59

Brief Summary

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

Conditions

Type 2 Diabetes

Keywords

diabetes; exenatide; Amylin; Lilly; metformin; pioglitazone; insulin glargine

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Hemoglobin (HbA1c)

  Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.

  baseline and 30 weeks

Secondary Outcomes (16)

• Percentage of Patients Achieving HbA1c <=7%

  baseline and 30 weeks

• Percentage of Patients Achieving HbA1c <=6.5%

  baseline and 30 weeks

• Change in Fasting Serum Glucose

  baseline and 30 weeks

• Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

  baseline and 30 weeks

• Change in Total Cholesterol

  baseline and 30 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: placebo

2

EXPERIMENTAL

Drug: exenatide

Interventions

placebo DRUG

subcutaneous injection, twice a day

1

exenatide DRUG

subcutaneous injection, twice a day, 10mcg

2

Eligibility Criteria

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

You may qualify if:

• Have type 2 diabetes.
• Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.
• Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:
• metformin (stable dose for 6 weeks)
• pioglitazone (stable dose for 6 weeks)
• a combination of metformin and pioglitazone (stable dose for 6 weeks)
• Have HbA1C between 7.1% and 10.5%, inclusive.
• Have a body mass index (BMI) ≤45 kg/m2.
• Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).

You may not qualify if:

• Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
• Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
• Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
• Women who are breastfeeding.
• Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
• Have had a kidney transplant or are currently on kidney dialysis.
• Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
• Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
• Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
• Are currently on a weight-loss program or have been on one within 3 months of entering the study.
• Have had a blood transfusion or severe blood loss within 3 months of entering the study.
• Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
• Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
• Have a history of pancreatitis.
• Have received treatment with an experimental drug within 30 days of entering the study.

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (59)

Research Site

Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Buena Park, California, United States

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Concord, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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La Mesa, California, United States

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Lancaster, California, United States

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Northridge, California, United States

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Palm Springs, California, United States

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Salinas, California, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Idaho Falls, Idaho, United States

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Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Lafayette, Louisiana, United States

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Matairie, Louisiana, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Berkeley Heights, New Jersey, United States

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Teaneck, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Bend, Oregon, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Georgetown, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Vancouver, Washington, United States

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Kenosha, Wisconsin, United States

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Athens, Greece, Greece

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Thessaloniki, Greece, Greece

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Holon, Israel, Israel

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Kfar Saba, Israel, Israel

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Tel Litwinsky, Israel, Israel

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Coatzacoalcos, Mexico, Mexico

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Monterrey, Mexico, Mexico

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México, State of Mexico, Mexico

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Carolina, Puerto Rico

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Hato Rey, Puerto Rico

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Ponce, Puerto Rico

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San Juan, Puerto Rico

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Birmingham, United Kingdom, United Kingdom

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Guildford, United Kingdom, United Kingdom

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Leicester, United Kingdom, United Kingdom

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Livingston, United Kingdom, United Kingdom

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Middlesbrough, United Kingdom, United Kingdom

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Swansea, United Kingdom, United Kingdom

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Torquay, United Kingdom, United Kingdom

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Related Publications (5)

• Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.

  PMID: 24621255 DERIVED

• Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5.

  PMID: 23043166 DERIVED

• Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.

  PMID: 22913891 DERIVED

• Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19.

  PMID: 22432107 DERIVED

• Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6.

  PMID: 21138825 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide

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

Results Point of Contact

• Title: Peter Ohman, Medical Science Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 24, 2016
• Results First Posted: January 26, 2011

Record last verified: 2016-10

Locations

IL (3); GB (7); ME (3); GR (2); US (40); PR (4)