Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2009/091/000609
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Diabetes Mellitus, Type 2
-Have been receiving metformin plus at least one other oral antihyperglycemic medication (sulfonylurea or TZD) without insulin, for at least 90 days prior to Visit 1
-HbA1c greater than or equal to 7.0% and less than 11.0%
regularly consume a light breakfast (less than 15% of total daily calorie intake)
-Capable and willing to follow the protocol
-Give written consent
-Are taking a TZD whose country label does not allow in combination with insulin
-Are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
-Have a body mass index greater than 40 kg/m2
-Have a history of severe hypoglycemia in past 24 weeks
-Are pregnant or may become pregnant
-Women who are breastfeeding
-Have significant cardiac disease
-Have significant renal or liver disease
-Undergoing therapy for a malignancy
-Contraindications to study medications
-Have an irregular sleep/wake cycle
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method