Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00110370
First received: May 6, 2005
Last updated: November 26, 2007
Last verified: November 2007
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Purpose
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Lispro Mixture Therapy Drug: Glargine Basal-Bolus Therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
- in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
- with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
- (A1C less than 7%) with once-daily insulin glargine in combination with OADs.
Secondary Outcome Measures:
- To test in both arms the following: frequency and incidence
- of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
- body weight, SAE's and study drug related AEs.
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2004 |
| Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have type 2 diabetes.
- Must be 30-75 years of age at the time of Visit 1.
- Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
- Must be on at least 30 units of glargine per day at enrollment.
- Have an A1C between 7.5% and 12.0% at Visit 1.
Exclusion Criteria:
- Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
- Must not have more than one episode of severe hypoglycemia in the last 6 months.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have congestive heart failure that requires medications.
- Must not have had a kidney transplant or currently receiving dialysis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110370
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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 from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00110370 History of Changes |
| Other Study ID Numbers: | 9057, F3Z-US-IOOQ |
| Study First Received: | May 6, 2005 |
| Last Updated: | November 26, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Glargine Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013