Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00641407|
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 31, 2008
The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications, but is difficult to achieve, despite the administration of escalating doses of oral antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients eventually require insulin which usually is added when glycemic control with a regimen of oral antidiabetic agents becomes suboptimal.
The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient who may benefit more by the single treatment.
This an open-label, randomized, parallel, 36-week comparative study was performed between January 2007 and March 2008 at a single centre.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Hypoglycemia||Drug: NPL insulin Drug: Insulin glargine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bedtime Insulin Glargine or Bedtime Neutral Protamine Lispro Combined With Sulfonylurea and Metformin in Type 2 Diabetes. A Randomized, Controlled Trial|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||March 2008|
Drug: NPL insulin
Starting dose 10 IU bedtime and then titration
|Active Comparator: 2||
Drug: Insulin glargine
10 IU bedtime and then titration
- Change in hemoglobin A1c (HbA1c) level from baseline to end point for each treatment group. [ Time Frame: 9 months ]
- Percentage of subjects achieving HbA1c ≤7%, incidence of self-reported hypoglycaemic episodes, comparison of SMPG values from 8-point profiles, insulin doses, and body weight. [ Time Frame: 9 months ]
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): NCT00641407
|Department of Geriatrics and Metabolic Disease|
|Naples, Italy, 80138|
|Principal Investigator:||Dario Giugliano, MD,PhD||Department of Geriatrics and Metabolic Diseases|