A Study in Patients With Type 2 Diabetes Mellitus (AWARD-2) - Full Text View

Purpose

The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HBA1c)and safe, as compared to Insulin Glargine in patients with Type 2 Diabetes. Patients must also be taking metformin and glimepiride.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin Glargine Drug: LY2189265 Drug: Metformin Drug: Glimepiride	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Insulin human Glimepiride Insulin glargine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to 26 weeks and 78 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 26, 52 and 78 weeks for body weight [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Change from baseline to 26, 52 and 78 weeks for blood glucose values from the 8-point self-monitored blood glucose (SMGB), profiles [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 26, 52 and 78 weeks in the EuroQol 5 Dimension [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 26, 52 and 78 weeks in the Impact of Weight on Activities of Daily Living [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 26, 52 and 78 weeks in the Impact of Weight on Self-Perception [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 26, 52 and 78 weeks in the Low Blood Sugar Survey [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 26, 52 and 78 weeks on electrocardiogram parameters [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Number of reported and adjudicated cardiovascular events at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Change in baseline to 26, 52 and 78 weeks on pulse rate [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Change from baseline to 26, 52 and 78 weeks on blood pressure [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Number of events of pancreatitis at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Change from baseline to 26, 52 and 78 weeks on pancreatic enzymes [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Change from baseline to 26, 52 and 78 weeks on serum calcitonin [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Number of self-reported hypoglycemic events at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Percentage of patients requiring additional intervention due to hyperglycemia at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Incidence of LY2189265 antibodies at 26, 52, 78 weeks and 4 weeks after last dose of study drug, so 83 weeks at the maximum [ Time Frame: Baseline, 26, 52, 78 and 83 weeks ] [ Designated as safety issue: Yes ]
Incidence of treatment emergent adverse events at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
Number of patients achieving HbA1c less than 7% at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
Number of patients achieving HbA1c less than or equal to 6.5% at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 52 and 78 weeks in glucagon concentration [ Time Frame: Baseline, 52 and 78 weeks ] [ Designated as safety issue: No ]
Change from baseline to 52 and 78 weeks in HOMA2-%S and HOMA2%B [ Time Frame: Baseline, 52 and 78 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	837
Study Start Date:	February 2010
Study Completion Date:	November 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 0.75 mg LY2189265	Drug: LY2189265 Administered as subcutaneous injection, once weekly for 78 weeks Other Name: Dulaglutide Drug: Metformin Administered orally at least 1500 milligram per day (mg/day) Drug: Glimepiride Administered orally at least 4 mg/day
Experimental: 1.5 mg LY2189265	Drug: LY2189265 Administered as subcutaneous injection, once weekly for 78 weeks Other Name: Dulaglutide Drug: Metformin Administered orally at least 1500 milligram per day (mg/day) Drug: Glimepiride Administered orally at least 4 mg/day
Active Comparator: Insulin Glargine	Drug: Insulin Glargine Administered as subcutaneous injection with dose titration based on blood glucose measures once daily for 78 weeks Drug: Metformin Administered orally at least 1500 milligram per day (mg/day) Drug: Glimepiride Administered orally at least 4 mg/day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes not well controlled on 1,2,or 3 oral diabetic medications (at least one of them must be metformin and/or sulfonylurea)
1. HbA1c greater than or equal to 7 and less than or equal to 11 if taking 1 oral diabetic medication
2. HbA1c greater than or equal to 7 and less than 10 if on 2 or 3 oral diabetic medications
Able to tolerate minimum dose of 1500 mg metformin a day and glimepiride 4 mg per day.
Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for insulin glargine.
Stable weight for 3 months prior to screening
BMI (body mass index) between 23 and 45 kg/m2
Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.

Exclusion Criteria:

Type 1 Diabetes
HbA1c equal to or less than 6.5 at randomization
Chronic Insulin use
Taking drugs to promote weight loss by prescription or over the counter
Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
History of Heart Failure New York Heart Classification III, or IV or acute myocardial infarction or stroke within 2 months of screening
GI (stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
Acute or chronic pancreatitis of any form
Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 ml/min
History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
A serum calcitonin greater than or equal to 20 pcg/ml at screening
Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
Organ transplant except cornea
Have enrolled in another clinical trial within the last 30 days
Have previously signed an informed consent or participated in a LY2189265 study
Have taken a GLP-1 receptor agonist within the 3 months prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075282

Show 78 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01075282 History of Changes
Other Study ID Numbers:	11374, H9X-MC-GBDB
Study First Received:	February 23, 2010
Last Updated:	January 22, 2013
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Brazil: Ministry of Health Canada: Health Canada United States: Food and Drug Administration India: Ministry of Health Mexico: Ministry of Health South Korea: Korea Food and Drug Administration (KFDA) Taiwan: Department of Health Belgium: Federal Agency for Medicinal Products and Health Products Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency Slovakia: State Institute for Drug Control Spain: Spanish Agency of Medicines Sweden: Medical Products Agency

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Metformin

Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013