A Study for Patients With Type 2 Diabetes

Lilly logo


Status and phase

Phase 2


Diabetes Mellitus, Type 2


Drug: LY2605541
Drug: insulin glargine

Study type


Funder types



I2R-MC-BIAC (Other Identifier)

Details and patient eligibility


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.

Full 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 neutral protamine Hagedorn (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.


289 patients




18+ years old


No Healthy Volunteers

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 unit/kilogram/day (U/kg/day). Oral antihyperglycemic medications (OAMs): Metformin dose at least 1500 milligram/day (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.
  • Hemoglobin A1c (HbA1c) less than or equal to 10.5% before randomization
  • Body Mass Index (BMI) 19 to 45 kilogram/square meter (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 milligram/deciliter (mg/dL) (177 micromole/Liter [μmol]/L)
  • Cardiac disease with a marked impact on physical functioning
  • Clinically significant electrocardiogram (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

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

289 participants in 3 patient groups

LY2605541 Dosing Algorithm 1
Experimental group
Participants took both LY2605541 and their pre-study insulin for first several days
Drug: LY2605541
LY2605541 Dosing Algorithm 2
Experimental group
Participants took only LY2605541 with first dose doubled
Drug: LY2605541
Insulin glargine
Active Comparator group
Drug: insulin glargine

Trial contacts and locations



Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems