A Study for Patients With Type 2 Diabetes - Full Text View

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:

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

Drug Information available for: Insulin human Insulin glargine

U.S. FDA Resources

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):

Bergenstal RM, Rosenstock J, Arakaki RF, Prince MJ, Qu Y, Sinha VP, Howey DC, Jacober SJ. A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2140-7. doi: 10.2337/dc12-0060. Epub 2012 Oct 9.

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 May 19, 2013