Comparison of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs, in subjects with type 2 diabetes
- Conditions
- Diabetes mellitus, Diabetes Mellitus, Type 2.,
- Registration Number
- CTRI/2010/091/000022
- Lead Sponsor
- Novo Nordisk AS
- Brief Summary
The aim of this clinical trial is to compare NN5401 with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral antidiabetic drugs (OADs). Subjects will continue their ongoing treatment with OADs (oral anti-diabetic drugs) in the trial.Trial ID: NN5401-3593No of subjects enrolled in India: Randomised: 108First patient first Visit:04 Mar 2010
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 450
- Type 2 diabetes mellitus for at least 6 months Ongoing daily treatment with a basal insulin (insulin detemir, insulin glargine, or insulin NPH) once daily for at least 3 months Ongoing treatment with metformin with our without other OADs (oral anti-diabetic drugs) for at least 3 months HbA1c 7.0 ?
- 10.0 % (both inclusive) BMI (Body Mass Index) at most 40.0 kg/m2 Age 18 Years and older.
Treatment with other insulin regimens than those listed in key inclusion criterion within the last 3 months Treatment with rosiglitazone, or GLP-1 receptor agonists within the last 3 months Significant cardiovascular disease within the last 6 months Uncontrolled treated/untreated severe hypertension Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures Impaired liver or renal function Cancer and medical history of cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c change from baseline After 26 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Plasma glucose profiles After 26 weeks of treatment
Trial Locations
- Locations (9)
Belgaum Diabetes Centre
🇮🇳Belgaum, KARNATAKA, India
Centre for Diabetes and Endocrine Diseases
🇮🇳apartment,Swaroop, India
Dia Care
🇮🇳Ahmadabad, GUJARAT, India
Diabetes Care Centre
🇮🇳Thiruvananthapuram, KERALA, India
Kanungo Institute of Diabetes Specialities Pvt Ltd,
🇮🇳Plot, No:1120,,Dumduma,, India
KMC Hospital
🇮🇳Bangalore, KARNATAKA, India
Life Care Clinic & Research Centre
🇮🇳Bangalore, KARNATAKA, India
Osmania General Hospital,
🇮🇳Hyderabad, ANDHRA PRADESH, India
Sahyadri Hospital
🇮🇳Pune, MAHARASHTRA, India
Belgaum Diabetes Centre🇮🇳Belgaum, KARNATAKA, IndiaDr.Neetha DeshpandePrincipal investigator919880271313neetarohit@gmail.com