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Clinical Trials/NCT01774968
NCT01774968
Completed
Phase 4

Two Treatment Approaches for Human Regular U-500 Insulin (Thrice-Daily Versus Twice-Daily) in Subjects With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial

Eli Lilly and Company1 site in 1 country325 target enrollmentStarted: February 2013Last updated:
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ConditionsDiabetes Mellitus, Type 2
InterventionsHuman Regular U-500 Insulin
DrugsHuman Regular U-500 Insulin

Overview

Phase
Phase 4
Status
Completed
Enrollment
325
Locations
1
Primary Endpoint
Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Have type 2 diabetes mellitus (World Health Organization \[WHO\] Classification of Diabetes)
  • •Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m\^2)
  • •Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry
  • •Current U-100 insulin/analogue users on \>200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization
  • •Have a history of stable body weight for at least 3 months prior to study entry
  • •Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months

Exclusion Criteria

  • •Have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus
  • •Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
  • •Have chronic kidney disease stage 4 and higher or history of renal transplantation
  • •Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to study entry
  • •Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry
  • •Have received U-500R in the 3 months prior to study entry
  • •Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia
  • •Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry
  • •Have an irregular sleep/wake cycle
  • •Have used rosiglitazone, once- or twice-daily glucagon-like peptide-1 (GLP-1) receptor agents, pramlintide, or other injectable or oral antihyperglycemic therapy not listed in the inclusion criteria in the 3 months prior to study entry. Participants may not have used once-weekly GLP-1 receptor agents in the 4 months prior to study entry

Arms & Interventions

Human Regular U-500 Insulin TID

Experimental

Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.

Intervention: Human Regular U-500 Insulin (Drug)

Human Regular U-500 Insulin BID

Experimental

U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.

Intervention: Human Regular U-500 Insulin (Drug)

Outcomes

Primary Outcomes

Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)

Time Frame: Baseline, Week 24

Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or \>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.

Secondary Outcomes

  • Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24(Week 24)
  • 30-Day Adjusted Rate of Hypoglycemic Events(Baseline through Week 24)
  • Change From Baseline to Week 24 in Body Weight(Baseline, Week 24)
  • Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin(Baseline, Week 24)
  • Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin(Baseline, Week 24)
  • Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels(Baseline, Week 24)
  • Time to Reach HbA1c Target Values(Baseline through 6, 12, 18, and 24 weeks.)
  • Percentage of Participants With Hypoglycemic Events(Baseline through Week 24)
  • Change From Baseline to Week 24 in Number of Insulin Injections(Baseline, Week 24)
  • Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)(Baseline, Week 24)
  • Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg(Baseline, Week 24)
  • Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg(Baseline, Week 24)
  • Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg(Baseline, Week 24)
  • Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg(Baseline, Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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