Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: Insulin Lispro Protamine Suspension Drug: Detemir	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Protamine Insulin human Insulin lispro

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks [ Time Frame: Baseline, 12 Weeks, 24 Weeks ] [ Designated as safety issue: No ]
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Glycemic Variability [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: Yes ]
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: Yes ]
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: Yes ]
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: Yes ]
Total Daily Insulin Dose (Units) at Endpoint [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Number of Injections of Basal Insulin Analog at Endpoint [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment:	442
Study Start Date:	August 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Insulin Lispro Protamine Suspension Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.	Drug: Insulin Lispro Protamine Suspension Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. Other Names: Neutral Protamine Lispro (NPL) Humalog ILPS
Active Comparator: Detemir Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.	Drug: Detemir Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494013

Show 56 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.

Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00494013 History of Changes
Other Study ID Numbers:	10935, F3Z-MC-IOOY
Study First Received:	June 27, 2007
Results First Received:	September 25, 2009
Last Updated:	November 4, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

diabetes
type 2

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Insulin
Protamines

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013