ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00494013
  Purpose

The purpose of this study is to examine the effectiveness and safety of lispro suspension 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 III

MedlinePlus related topics:   Diabetes   

Drug Information available for:   Insulin    Insulin lispro    Protamine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change in Hemoglobin A1c. [ Time Frame: Baseline to twenty four weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Actual and change from baseline HbA1c value at 12 weeks and at endpoint [ Time Frame: 12-24 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: Yes ]
  • 7-point self-monitored blood glucose (SMBG) profile at endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Glycemic variability at endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence, rate (30-day and 1-year adjusted), and percent reduction (for incidence and rate) of self-reported hypoglycemic episodes (throughout the study and at endpoint), including nocturnal and non-nocturnal; and severe hypoglycemia [ Time Frame: Visits 3, 4, 5, 6, 7, 8, 9, Early Term ] [ Designated as safety issue: Yes ]
  • Absolute body weight (kg) and incremental weight change from baseline to endpoint [ Time Frame: Every office visit, Early Term ] [ Designated as safety issue: Yes ]
  • Treatment-emergent adverse events (TEAEs) [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Total daily insulin dose 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 ]
  • Intrapatient glycemic variability as measured from self-monitored blood glucose (SMBG) profiles at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:   377
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
1: Experimental
Insulin Lispro Protamine Suspension
Drug: Insulin Lispro Protamine Suspension
Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
2: Active Comparator
Detemir
Drug: Detemir
Patient specific dose administered subcutaneously once 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:

  1. Have type 2 diabetes mellitus for at least 1 year.
  2. Are at least 18 years old.
  3. 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 mg/day; Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-IV (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.
  4. 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.
  5. Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m2.

Exclusion Criteria

  1. 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.
  2. 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.
  3. 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.
  4. Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 mg/dL (177 micromol/L).
  5. 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  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


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

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   10935, F3Z-MC-IOOY
First Received:   June 27, 2007
Last Updated:   October 1, 2008
ClinicalTrials.gov Identifier:   NCT00494013
Health Authority:   United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
diabetes  
type 2  

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Insulin LISPRO
Endocrine System Diseases
Protamines
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Heparin
Insulin
Calcium heparin

Additional relevant MeSH terms:
Hypoglycemic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Physiological Effects of Drugs
Heparin Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008




Links to all studies - primarily for crawlers