A 2-year clinical trial comparing the effectiveness of IDegLira against insulin glargine in being able to control blood glucose in patients with Type II Diabetes who are inadequately controlled on oral anti-diabetics
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2016/05/006966
- Lead Sponsor
- ovo Nordisk Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial
2. Male or female, age >= 18 years at the time of signing informed consent
3. Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to the day of screening
4. HbA1c 7.0â??11.0% (both inclusive) (53â??97 mmol/mol) by central laboratory analysis
5. Body mass index (BMI) >= 20 kg/m2
6. Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to
the day of screening is allowed, as is prior insulin treatment for gestational diabetes
7. Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days
prior to the day of screening:
ï?· Biguanides (metformin >= 1500 mg or maximum tolerated dose documented in the subject
medical record)
ï?· Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (>= half of
the maximum approved dose according to local label or maximum tolerated dose as
documented in subject medical record)
1. Known or suspected hypersensitivity to trial products or related products
2. Previous participation in this trial. Participation is defined as signed informed consent. Rescreening is not allowed
3. Female who is pregnant, breast-feeding or intend to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
4. Receipt of any investigational medicinal product within 90 days prior to screening
Brazil: Participation in other trials within 1 year prior to screening visit (visit 1) unless there is a direct benefit to the research subject at the investigatorâ??s discretion.
5. Any disorder which in the opinion of the investigator might jeopardise subjectâ??s safety or compliance with the protocol
6. Screening calcitonin >= 50 ng/L
7. Renal impairment estimated Glomerular Filtration Rate (eGFR) 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening11
8. Impaired liver function, defined as ALAT or ASAT >= 2.5 times upper limit of normal
9. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) in the previous 90 days prior to the day of the screening
10. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroids Carcinoma
11. History of pancreatitis (acute or chronic)
12. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening
13. Subjects presently classified as being in NYHA Class IV
14. Planned coronary, carotid or peripheral artery revascularisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method