A Study for Type 2 Diabetic Patients
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00548808
First received: October 22, 2007
Last updated: August 20, 2010
Last verified: August 2010
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Purpose
The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Insulin lispro low mixture Drug: Insulin glargine Drug: Insulin lispro |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Hemoglobin A1c (HbA1c) Over Time [ Time Frame: Baseline, 16 Weeks, 32 Weeks, 48 Weeks ] [ Designated as safety issue: No ]
- Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time [ Time Frame: 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
- 7-point Self-monitored Blood Glucose Profiles [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in Postprandial Blood Glucose Over Time [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.
- Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks [ Time Frame: 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
- Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks [ Time Frame: 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
- Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: Yes ]
- Safety: Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: baseline through 48 weeks ] [ Designated as safety issue: Yes ]Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.
| Enrollment: | 426 |
| Study Start Date: | November 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Insulin lispro low mixture
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Drug: Insulin lispro low mixture
Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
Other Name: LY275585[P]
|
|
Active Comparator: Insulin glargine
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
Drug: Insulin glargine
Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
Drug: Insulin lispro
Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
Other Name: LY275585
|
Eligibility| Ages Eligible for Study: | 30 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus
- Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
- Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
- Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
- Able to perform self monitoring of blood glucose
Exclusion Criteria:
- Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
- Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
- Have a body mass index greater than 35 kg/m2
- History or presence of kidney disease
- Have cardiac disease (Class III or IV)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548808
Show 25 Study Locations
Show 25 Study LocationsSponsors 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:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00548808 History of Changes |
| Other Study ID Numbers: | 11541, F3Z-CR-IOPH |
| Study First Received: | October 22, 2007 |
| Results First Received: | August 20, 2010 |
| Last Updated: | August 20, 2010 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Brazil: National Health Surveillance Agency Canada: Health Canada China: Food and Drug Administration India: Indian Council of Medical Research Mexico: Federal Commission for Sanitary Risks Protection South Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin LISPRO |
Glargine Insulin Hypoglycemic Agents Insulin, Long-Acting Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013