A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus

NCT00630825 | Completed Phase 2 Results

• 2 other identifiers: 12068H9X-MC-GBCJ
• Study Type: interventional
• Target: 262
• Locations: 2 countries
• Sites: 34

Brief Summary

To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus

  Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).

  Baseline, 16 weeks

Secondary Outcomes (15)

• Change From Baseline in Fasting Blood Glucose

  Baseline, 16 weeks

• Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)

  Baseline and 16 weeks

• Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles

  2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.

• Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)

  Baseline, 16 weeks

• Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%

  Baseline and 4 and 8 and 16 weeks

Study Arms (4)

1.0/2.0 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks

Drug: LY2189265

1.0/1.0 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks

Drug: LY2189265

0.5/1.0 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks

Drug: LY2189265

Placebo

PLACEBO COMPARATOR

Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks

Drug: Placebo

Interventions

LY2189265 DRUG

Also known as: Dulaglutide

0.5/1.0 milligram (mg) LY2189265; 1.0/1.0 milligram (mg) LY2189265; 1.0/2.0 milligram (mg) LY2189265

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Type 2 Diabetes Mellitus \>3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007).
• Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
• Have glycosylated hemoglobin (HbA1c) of \>7.0% to ≤10.5% as determined by central laboratory at screening.
• Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m\^2), inclusive.
• Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).

You may not qualify if:

• Have known Type 1 Diabetes Mellitus
• Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)
• Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty \[PTCA\], open heart surgery, or coronary artery bypass graft \[CABG\]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
• Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) \>2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.
• Currently taking prescription or over the counter medications to prevent weight loss.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (34)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Peoria, Arizona, 85381, United States

Location

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Anaheim, California, 92805, United States

Location

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Lancaster, California, 93534, United States

Location

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Northridge, California, 91326, United States

Location

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Palm Springs, California, 92262, United States

Location

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South Miami, Florida, 33143, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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Athens, Georgia, 30606, United States

Location

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Atlanta, Georgia, 30303, United States

Location

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Springfield, Illinois, 62704, United States

Location

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Indianapolis, Indiana, 46250, United States

Location

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Biddeford, Maine, 04005, United States

Location

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Ann Arbor, Michigan, 48108, United States

Location

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Bloomfield Hills, Michigan, 48302, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Billings, Montana, 59101, United States

Location

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Flemington, New Jersey, 08822, United States

Location

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Syracuse, New York, 13210, United States

Location

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Greensboro, North Carolina, 27401, United States

Location

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Greenville, North Carolina, 27834, United States

Location

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Morehead City, North Carolina, 28557, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Austin, Texas, 78731, United States

Location

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Dallas, Texas, 75230, United States

Location

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San Antonio, Texas, 78237, United States

Location

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Norfolk, Virginia, 23510, United States

Location

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Renton, Washington, 98057, United States

Location

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Spokane, Washington, 99216, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Wenatchee, Washington, 98801, United States

Location

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Menomonee Falls, Wisconsin, 53051, United States

Location

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Manatí, 00674, Puerto Rico

Location

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San Juan, 00907, Puerto Rico

Location

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Toa Baja, 00949, Puerto Rico

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM 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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 10, 2014
• Results First Posted: December 10, 2014

Record last verified: 2014-12

Locations

US (31); PR (3)