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Phase 2 N=138 Randomized Treatment

A Study for Patients With Type 1 Diabetes

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT01049412 ↗
Enrolled (actual)
138
Serious AEs
3.9%
Results posted
Apr 2018
Primary outcome: Primary: Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles — 7.98; 8.53 millimole per Liter (mmol/L) — p=<0.001

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

OutcomeResultp-value
PRIMARY
Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles		 7.98; 8.53 <0.001 sig
SECONDARY
Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles		 -0.74; -0.18 <0.001 sig
SECONDARY
Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I		 -0.45; -0.34 0.242
SECONDARY
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I		 43.1; 33.3; 24.6; 13.3 0.276
SECONDARY
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I)		 1.5; 1.7; 0; 0 —
SECONDARY
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint		 8.97; 8.67; 9.33; 9.57; 8.27; 8.76 0.392
SECONDARY
Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint		 3.35; 2.58; 4.12; 2.86 —
SECONDARY
Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 8 Endpoint		 2873 —
SECONDARY
Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20		 8.3; 3.3; 3.3; 5.0; 12.5; 7.4 —
SECONDARY
Percentage of Participants With Hypoglycemia Baseline Through Week 8		 92.7; 90.0 —
SECONDARY
Rate of Hypoglycemia Per 30 Days Baseline Through Week 8		 8.74; 7.36 0.037 sig
SECONDARY
Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint		 3.13; 3.60 <0.001 sig

Summary

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

Eligibility 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 unit per kilogram (U/kg).
  • Hemoglobin A1c (HbA1c) of no greater than 10.5% before randomization
  • Body mass index (BMI) 19 to 45 kilogram per square meter (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 electrocardiogram (ECG) abnormalities at screening
  • Fasting triglycerides greater than 500 milligram per deciliter (mg/dL)
  • Liver disease
  • History of renal transplantation, current renal dialysis, or creatinine greater than 2.0 mg/dL (177 micromole per liter [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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01049412). 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.

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