A Study for Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01027871
First received: December 8, 2009
Last updated: April 5, 2011
Last verified: March 2011
  Purpose

Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2605541
Drug: insulin glargine
Phase 2

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 Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Fasting blood glucose at 12-week endpoint of treatment as measured by the 8-point self-monitored blood glucose profiles [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting blood glucose from baseline to 12-week endpoint [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • HbA1c change from baseline to 12-week endpoint [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with HbA1c <7.0% and less than or equal to 6.5% at 12-week endpoint [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with HbA1c <7.0% and HbA1c less than or equal to 6.5% at 12-week endpoint who did not experience a hypoglycemic episode during treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 8-point self-monitored blood glucose measures at 12-week endpoint [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Daily basal insulin dose [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with hypoglycemia from baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Rate of hypoglycemia per 30 days from baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • LY2605541 antibody titers [ Time Frame: Baseline, Week 12 , and Week 16 ] [ Designated as safety issue: Yes ]
  • Variability in fasting blood glucose [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Concentration at steady state (Css) [ Time Frame: Baseline, Weeks 4, 8, 10, 12, and 16 ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose from baseline to 12-week endpoint - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • HbA1c change from baseline to 12-week endpoint - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with HbA1c <7.0% and less than or equal to 6.5% at 12-week endpoint - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with HbA1c <7.0% and HbA1c less than or equal to 6.5% at 12-week endpoint who did not experience a hypoglycemic episode during treatment - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 8-point self-monitored blood glucose measures at 12-week endpoint - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Daily basal insulin dose - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with hypoglycemia from baseline to Week 12 - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Rate of hypoglycemia per 30 days from baseline to Week 12 - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Variability in fasting blood glucose - subgroup analysis of LY2605541 dosing algorithms [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2605541 Dosing Algorithm 1 Drug: LY2605541
subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
Experimental: LY2605541 Dosing Algorithm 2 Drug: LY2605541
subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
Active Comparator: Insulin glargine Drug: insulin glargine
subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks

Detailed Description:

Patients in this study will continue to use their stable prestudy dose of metformin and/or a sulfonylurea. Prestudy therapy also includes once daily insulin glargine or NPH insulin. The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will return to the basal insulin recommended by the investigator.

  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes mellitus (T2DM) for at least 1 year
  • At least 18 years of age
  • Using metformin and/or sulfonylurea(s) with once daily glargine or NPH for at least 3 months prior to the study. Prestudy dose requirements: insulin dose maximum 1.0 U/kg/day. Oral antihyperglycemic medications (OAMs): Metformin dose at least 1500 mg/day and/or sulfonylurea dose at least half the maximum daily dose specified in the local package insert. OAM doses stable for 6 weeks prior to the study.
  • HbA1c less than or equal to 10.5% before randomization
  • BMI 19 to 45 kg/m2
  • Capable and willing to prepare and inject insulin with a syringe while continuing to use the prestudy OAMs, monitor own blood glucose; complete the study diary; be receptive to diabetes education; comply with study visits and receive telephone calls between visits
  • Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up visit

Exclusion Criteria:

  • Long-term use of short- or rapid-acting or premixed insulin within the 6 months before the study. Short-term insulin therapy or occasional use are permitted
  • Use of any glucose-lowering medications not allowed by the inclusion criteria in the 3 months before entry into the study
  • Use of prescription or over-the-counter medications to promote weight loss within 3 months before entry into the study
  • Current participation in a weight loss program, or plans to do so during the study
  • Treatment with any antibody-based therapy within 6 months prior to the study
  • Use of chronic (>14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
  • More than 1 episode of severe hypoglycemia within 6 months prior to the study, or currently diagnosed with hypoglycemia unawareness
  • 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
  • Liver disease
  • History of renal transplantation, current renal dialysis, or creatinine >2.0 mg/dL (177 μmol/L)
  • Cardiac disease with a marked impact on physical functioning
  • Clinically significant ECG abnormalities at screening
  • Malignancy other than basal cell or squamous cell skin cancer
  • Fasting triglycerides >500 mg/dL
  • Known diabetic autonomic neuropathy
  • Known hypersensitivity or allergy to study insulin or its excipients
  • Blood transfusion or severe blood loss within 3 months prior to entry into the study or known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology
  • Irregular sleep/wake cycle
  • Women who are breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027871

  Show 25 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 by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01027871     History of Changes
Other Study ID Numbers: 12149, I2R-MC-BIAC
Study First Received: December 8, 2009
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014