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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014