Phase 3 N=442 Randomized Treatment

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

Diabetes Mellitus Type 2

Bottom Line

View on ClinicalTrials.gov: NCT00494013 ↗

Enrolled (actual)

442

Serious AEs

1.9%

Results posted

Nov 2009

Primary outcome: Primary: Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) — 8.79; 8.77; -1.52; -1.31 percent of HbA1c — p=0.026

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Insulin Lispro Protamine Suspension (Drug); Detemir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)	8.79; 8.77; -1.52; -1.31	0.026 sig
SECONDARY Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks	8.79; 8.77; 7.44; 7.55; -1.33; -1.22	0.213
SECONDARY Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint	34.9; 31.2; 22.5; 16.3	0.463
SECONDARY Glycemic Variability	1.14; 1.04	0.107
SECONDARY 7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint	8.25; 8.26; 7.48; 7.43; 9.37; 9.42	0.952
SECONDARY Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods	151; 137; 99; 68; 5; 2	0.472
SECONDARY 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall	24.23; 16.23; 6.32; 3.75; 0.05; 0.01	0.001 sig
SECONDARY 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall	1.99; 1.33; 0.52; 0.31; 0.00; 0.00	—
SECONDARY Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint	81.10; 82.56; 1.88; 0.36	<0.001 sig
SECONDARY Total Daily Insulin Dose (Units) at Endpoint	31.78; 37.30	0.074
SECONDARY Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint	0.39; 0.46	0.039 sig
SECONDARY Number of Injections of Basal Insulin Analog at Endpoint	89; 108; 130; 102	0.026 sig

Summary

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Eligibility Criteria

Inclusion Criteria

Have type 2 diabetes mellitus for at least 1 year.
Are at least 18 years old.
Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

Exclusion Criteria

Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00494013). 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.