A Study for Type 2 Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT00548808|
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : September 15, 2010
Last Update Posted : September 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Insulin lispro low mixture Drug: Insulin glargine Drug: Insulin lispro||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||426 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
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 weeksDrug: 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
- Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 48 weeks ]
- Change in Hemoglobin A1c (HbA1c) Over Time [ Time Frame: Baseline, 16 Weeks, 32 Weeks, 48 Weeks ]
- Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time [ Time Frame: 16 weeks, 32 weeks, 48 weeks ]
- 7-point Self-monitored Blood Glucose Profiles [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ]
- Change From Baseline in Postprandial Blood Glucose Over Time [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ]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 ]
- Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks [ Time Frame: 16 weeks, 32 weeks, 48 weeks ]
- Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles [ Time Frame: baseline, 48 weeks ]
- Safety: Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: baseline through 48 weeks ]Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548808
Show 25 Study Locations
|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|