Phase 2
N=289
A Study for Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01027871 ↗Enrolled (actual)
289
Serious AEs
2.4%
Results posted
Jun 2018
Primary outcome: Primary: Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles — 6.83; 7.15; 6.84 millimoles per Liter (mmol/L) — p=0.433
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2605541 (Drug); insulin glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles |
6.83; 7.15; 6.84 | 0.433 |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint |
-1.77; -1.97 | 0.388 |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint |
-0.64; -0.74 | 0.197 |
| SECONDARY Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint |
48.4; 51.9; 23.1; 29.5 | 0.609 |
| SECONDARY Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment |
11.96; 16.49; 6.52; 7.98 | 0.375 |
| SECONDARY 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint |
9.54; 9.11; 7.47; 7.23; 9.49; 9.22 | 0.144 |
| SECONDARY Daily Basal Insulin Dose at Week 2 and Week 12 |
2.45; 3.19; 2.90; 4.58 | — |
| SECONDARY Percentage of Participants With Hypoglycemia From Baseline Through Week 12 |
63.4; 54.0 | 0.162 |
| SECONDARY Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 |
1.52; 1.34 | 0.804 |
| SECONDARY Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16 |
2.4; 4.7; 2.8; 2.4; 0.0; 1.1 | — |
| SECONDARY Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 |
1.52; 1.51; 1.23; 1.20 | 0.937 |
| SECONDARY Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint |
4258 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms |
-1.82; -2.22; -1.99 | 0.159 |
| SECONDARY Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms |
-0.65; -0.67; -0.83 | 0.880 |
| SECONDARY Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms |
48.4; 57.5; 50; 23.1; 31.5; 26.3 | 0.273 |
| SECONDARY Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms |
11.96; 21.33; 15.66; 6.52; 9.33; 7.23 | 0.139 |
| SECONDARY 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms |
6.76; 7.02; 6.62; 9.31; 9.05; 8.48 | 0.305 |
| SECONDARY Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms |
2.62; 3.23; 3.64; 3.15; 4.58; 5.26 | — |
| SECONDARY Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms |
63.4; 47.5; 54.2 | 0.046 sig |
| SECONDARY Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms |
1.52; 1.25; 1.27 | 0.561 |
| SECONDARY Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms |
1.43; 1.40; 1.42; 1.17; 1.16; 1.07 | 0.938 |
Summary
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01027871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.