A Study of Insulin Lispro in patient with Type 2 Diabetes
- Conditions
- Health Condition 1: null- Patients with Type 2 Diabetes
- Registration Number
- CTRI/2011/09/001987
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 478
Present with type 2 diabetes mellitus
-Have been taking metformin and/or pioglitazone
-Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
-Have HbA1c concentration between greater than or equal to 7.5% and less than or equal to 10.5
-Have a fasting plasma glucose concentration of less than or equal to 6.7 mmol/L (less than or equal to 121 mg/dL), or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
-Not pregnant or breastfeeding
-Have Type 1 Diabetes
-Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
-Have a body mass index (BMI) greater than 45 kg/m2.
-Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
-Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
-Have cardiac disease with a functional status that is Class III or IV
-Have a history of renal or liver disease
-Have had a blood transfusion or have a blood disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline to 24 weeks endpointTimepoint: Change in HbA1c from baseline to 24 weeks endpoint
- Secondary Outcome Measures
Name Time Method 7-point self-monitored blood glucose (SMBG)Timepoint: 12 weeks, 24 weeks;Change in the fasting plasma glucose concentration from baselineTimepoint: Baseline, 12 weeks, and 24 weeks;Change in the HbA1c concentration from baselineTimepoint: Baseline, 12 weeks;Change in weightTimepoint: Baseline, 12 weeks, 24 weeks;Daily insulin dose: total, basal, and prandialTimepoint: 12 weeks, 24 weeks;Glycemic variability from the 7-point SMBGTimepoint: 12 weeks, 24 weeks;incidence of hypoglycemic episodesTimepoint: over 24 weeks;Insulin Treatment Satisfaction Questionnaire (ITSQ)Timepoint: 24 weeks;Perceptions about Medications-Diabetes 21 (PAM-D21) questionnaireTimepoint: 24 weeks;Proportion of patients who achieve a target HbA1c concentration of less than7% or less than or equal to 6.5%Timepoint: 24 weeks;severity of hypoglycemic episodesTimepoint: over 24 weeks;The rate of hypoglycemic episodesTimepoint: over 24 weeks