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The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
This study is ongoing, but not recruiting participants.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00279201
  Purpose

This study will compare insulin lispro low mixture [LM] and insulin glargine in combination with the patient's oral diabetes medicines for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.

This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine in combination with the patient's oral diabetes medications.

The addendum study will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Glargine
Drug: Humalog Low Mix
 Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Insulin glargine Insulin lispro
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • INITIATION: Comparison of endpoint A1C after 6 months of starter insulin therapy with either insulin lispro low mixture [LM] twice-daily or insulin glargine. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MAINTENANCE: Comparison of the duration of time that each starter insulin regimen is able to maintain A1C at goal. [ Time Frame: 6 months - 5 years ] [ Designated as safety issue: Yes ]
  • ADDENDUM: Comparison of endpoint A1C after 6 months of second step intensification regimens in patients who have not achieved control during 6 months of starter insulin therapy. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • INITIATION+MAINTENANCE: Change in HbA1c from baseline to 6 months (initiation phase endpoint), baseline to maintenance phase endpoint and 6 months to maintenance phase endpoint [ Time Frame: 6 months - 5 years ] [ Designated as safety issue: Yes ]
  • MAINTENANCE+ADDENDUM: Percentage of patients with A1C < or = 7.0% and A1C < or = 6.5% [ Time Frame: 6 months - 5 years ] [ Designated as safety issue: Yes ]
  • MAINTENANCE+ADDENDUM: HbA1c at specified visits and endpoint [ Time Frame: Visits 1, 2, 4, 6-14, A3, A4, Early Term ] [ Designated as safety issue: Yes ]
  • MAINTENANCE+ADDENDUM: Blood glucose measurements during 7-point profiles at specified visits and endpoint [ Time Frame: Visits 2, 4, 6, 8, 10, 12, 14, A3, A4,Early Term ] [ Designated as safety issue: Yes ]
  • MAINTENANCE+ADDENDUM: Absolute and incremental weight change [ Time Frame: Every visit, endpoint ] [ Designated as safety issue: No ]
  • MAINTENANCE+ADDENDUM: Insulin dose (24 hour total IU and total IU/kg body weight) at each visit and endpoints [ Time Frame: Every visit, endpoint ] [ Designated as safety issue: No ]
  • MAINTENANCE+ADDENDUM: Incidence as well as rate of self-reported hypoglycemic episodes [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • ADDENDUM: Change in HbA1c from point of second randomization to endpoint [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • MAINTENANCE+ADDENDUM: 1,5-Anhydroglucitol [ Time Frame: Visits 2, 6, 10, 14, A4 or Early Term ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: December 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Insulin glargine once daily
Drug: Glargine
Insulin glargine SC once daily for up to 5 years
2: Experimental
Humalog Low Mix twice daily SC
Drug: Humalog Low Mix
Humalog LM SC twice daily for up to 5 years

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have type 2 diabetes.
  • Must be at least 30 and less than 80 years of age at the time of Visit 1.
  • Must be on at least two oral antidiabetes medications for at least 90 days.
  • Must have an A1C 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

Exclusion Criteria:

  • Must not have used insulin on a regular basis in the last 12 months.
  • Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
  • Must not have a body mass index (BMI) or greater than 45 (morbid obesity).
  • Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
  • Must not be pregnant or intend to get pregnant during course of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279201

  Show 199 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: 10455, F3Z-US-IOOV
Study First Received: December 15, 2005
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00279201  
Health Authority: United States: Food and Drug Administration;   Hungary: National Institute of Pharmacy;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Romania: National Medicines Agency;   Canada: Health Canada;   Greece: National Organization of Medicines;   Spain: Spanish Agency of Medicines;   Brazil: National Health Surveillance Agency;   India: Ministry of Health

Keywords provided by Eli Lilly and Company:
diabetes
type 2

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

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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