A Study in Patients With Type 2 Diabetes Mellitus (AWARD-4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01191268
First received: August 27, 2010
Last updated: November 8, 2012
Last verified: November 2012

August 27, 2010
November 8, 2012
November 2010
February 2012   (final data collection date for primary outcome measure)
Change from baseline to 26 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01191268 on ClinicalTrials.gov Archive Site
  • Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks for blood glucose values from the 8-point self-monitored blood glucose(SMBG) profiles [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients attaining HbA1c less than 7% and less than or equal to 6.5% at weeks 26 and 52 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 weeks, and 4 weeks after last dose for body weight [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks in total daily insulin lispro dose [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the EuroQoL5 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Impact of Weight on Self-Perception (IW-SP) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Low Blood Sugar Survey (LBSS) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on blood pressure [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Number of events of pancreatitis at 26 and 52 weeks, and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on pancreatic enzymes [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks and 52 weeks, and 4 weeks after last dose on serum calcitonin [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Number of self-reported hypoglycemic events at 26 weeks and 52 weeks, and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Presence of LY2189265 antibodies at 26 weeks and 52 weeks and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 , 52, and 4 weeks after last dose in Body Mass Index (BMI) [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks and 52 weeks in fasting blood glucose [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the percentage of patients achieving HbA1c <7% without nocturnal hypoglycemia [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study in Patients With Type 2 Diabetes Mellitus (AWARD-4)
The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)

The purpose of this study is to determine if LY2189265 in combination with insulin lispro is effective and safe in reducing hemoglobin A1c, as compared to insulin glargine in combination with insulin lispro in patients with Type 2 Diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Insulin Glargine
    Administered by subcutaneous injection once at bedtime dose dependent on treat to target algorithm for 52 weeks
  • Drug: LY2189265
    Administered once weekly by subcutaneous injection for 52 weeks
    Other Name: Dulaglutide
  • Active Comparator: Insulin Glargine
    Intervention: Drug: Insulin Glargine
  • Experimental: 1.5 mg LY2189265
    Intervention: Drug: LY2189265
  • Experimental: 0.75 mg LY2189265
    Intervention: Drug: LY2189265
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
837
September 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
  • HbA1c greater than or equal to 7% and less than or equal to 11%
  • Willing to inject subcutaneous medication
  • Willing to monitor blood glucose levels and adjust insulin dose
  • Willing to maintain a study diary
  • Body mass index (BMI) between 23 and 45 kg/m2
  • Stable weight for 3 months prior to screening
  • Females of child bearing potential must test negative for pregnancy at screening 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
  • Previous therapy with GLP 1 agonists within 3 months prior to screening
  • 1 or more episodes of ketoacidosis within 6 months prior to screening
  • Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
  • Estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min/1.73 m2 at screening
  • Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
  • History of heart failure, New York Heart Classification III, IV within 2 months prior to screening
  • GI (stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
  • Acute or chronic hepatitis or pancreatitis
  • Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
  • Serum calcitonin greater than or equal to 20 pcg/ml at screening
  • Organ transplant except cornea
  • Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
  • History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
  • Known drug or alcohol abuse
  • Have enrolled in another clinical trial within the last 30 days
  • Have previously signed an informed consent or participated in a LY2189265 study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Denmark,   Greece,   Hungary,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Sweden,   Taiwan
 
NCT01191268
11376, H9X-MC-GBDD
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP