A Study for Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01049412
First received: January 12, 2010
Last updated: April 5, 2011
Last verified: February 2011
  Purpose

Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: LY2605541
Drug: Insulin glargine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Daily average blood glucose as measured by the 8-point self-monitored blood glucose profiles [ Time Frame: 8 weeks of each treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 8 week endpoint for daily average blood glucose as measured by the 8-point self-monitored blood glucose profiles [ Time Frame: Baseline and 8 weeks of each treatment ] [ Designated as safety issue: No ]
  • HbA1c change from baseline to 8-week endpoint [ Time Frame: Baseline and 8 weeks (period 1) ] [ Designated as safety issue: No ]
  • Proportion of patients with HbA1c less than 7.0% and HbA1c less than or equal to 6.5% at 8-week endpoint [ Time Frame: 8 weeks (period 1) ] [ Designated as safety issue: No ]
  • Proportion of patients with HbA1c less than 7.0% and HbA1c less than or equal to 6.5% at 8-week endpoint who did not experience a hypoglycemic episode during treatment [ Time Frame: 8 weeks (period 1) ] [ Designated as safety issue: No ]
  • 8-point self-monitored blood glucose measures at 8-week endpoints [ Time Frame: 8 weeks of each treatment ] [ Designated as safety issue: No ]
  • Insulin dose [ Time Frame: Baseline; 2, 4, 6, and 8 weeks of each treatment; and 4 weeks (follow-up) ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Concentration at steady state (Css) [ Time Frame: Baseline; 2, 6, and 8 weeks (period 1); 2, 6, and 8 weeks (period 2) and 4 weeks follow-up ] [ Designated as safety issue: No ]
  • LY2605541 antibody titers [ Time Frame: Baseline; 8 weeks of each treatment; 4 weeks (follow-up) ] [ Designated as safety issue: Yes ]
  • Proportion of patients with hypoglycemia over 8-week treatment period [ Time Frame: 0 weeks to 8 weeks of each treatment ] [ Designated as safety issue: Yes ]
  • Rate of hypoglycemia per 30 days over 8-week treatment period [ Time Frame: 0 weeks to 8 weeks of each treatment ] [ Designated as safety issue: Yes ]
  • Variability in fasting blood glucose [ Time Frame: Baseline; 2, 4, 6 and 8 weeks of each treatment ] [ Designated as safety issue: No ]

Enrollment: 138
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 Drug: LY2605541
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.
Drug: Insulin glargine
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.
Active Comparator: Insulin glargine Drug: LY2605541
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.
Drug: Insulin glargine
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.

Detailed Description:

Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins. Patients will continue to use their mealtime insulins throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of follow-up. The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2) during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence. During the 4-week follow-up period, patients will return to insulin glargine or another basal insulin recommended by the investigator.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus (T1DM) for at least 1 year and using insulin glargine for at least 6 months with a maximum daily dose of 1 U/kg.
  • HbA1c of no greater than 10.5% before randomization
  • Body mass index (BMI) 19 to 45 kg/m2
  • Capable and willing to prepare and inject insulin with a syringe, monitor own blood glucose, complete the study diary, be receptive to diabetes education, comply with study requirements, and receive telephone calls during treatment
  • Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up

Exclusion Criteria:

  • Twice daily use of insulin glargine within 30 days prior to the study
  • Use of any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to the study
  • Use of an insulin pump
  • More than 1 episode of severe hypoglycemia within 3 months prior to the study, or currently diagnosed as having hypoglycemia unawareness
  • 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
  • Known hypersensitivity or allergy to any of the study insulins or their excipients
  • Blood transfusion or severe blood loss within 3 months prior to 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
  • Pregnant or intend to become pregnant during the study
  • Women who are breastfeeding
  • Use of prescription or over-the-counter medications to promote weight loss within 3 months prior to the study
  • Current participation in a weight loss program or plans to do so during the study
  • Use of chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
  • Cardiac disease with a marked impact on physical functioning
  • Clinically significant ECG abnormalities at screening
  • Fasting triglycerides greater than 500 mg/dL
  • Liver disease
  • History of renal transplantation, current renal dialysis, or creatinine greater than 2.0 mg/dL (177 μmol/L)
  • Malignancy other than basal cell or squamous cell skin cancer, currently or within the last 5 years
  • Treatment with any antibody-based therapy within 6 months prior to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049412

Locations
United States, California
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.
Chula Vista, California, United States, 91911
United States, Georgia
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.
Atlanta, Georgia, United States, 30309
United States, Idaho
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.
Idaho Falls, Idaho, United States, 83404
United States, Kansas
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.
Topeka, Kansas, United States, 66606
United States, Louisiana
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.
Metairie, Louisiana, United States, 70006
United States, Maryland
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.
Baltimore, Maryland, United States, 21204
United States, Minnesota
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.
Minneapolis, Minnesota, United States, 55416
United States, Texas
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.
Austin, Texas, United States, 78731
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.
Dallas, Texas, United States, 75230
United States, Washington
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.
Renton, Washington, United States, 98057
Israel
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.
Holon, Israel, 22100
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.
Petah Tiqva, Israel, 49451
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.
Tel Hashomer, Israel, 52661
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: NCT01049412     History of Changes
Other Study ID Numbers: 12151, I2R-MC-BIAD
Study First Received: January 12, 2010
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014