CTRI/2016/08/007216
Completed
Phase 3
A clinical trial comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus - DUAL IX
ovo Nordisk India Private Ltd0 sites52 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Type 2 DiabetesHealth Condition 2: E11- Type 2 diabetes mellitus
- Sponsor
- ovo Nordisk India Private Ltd
- Enrollment
- 52
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 greater than or equal to 18 years at the time of signing informed consent.
- •3\. Subjects diagnosed (clinically) with type 2 diabetes mellitus.
- •4\. HbA1c 7\.0\-11\.0% (53\-97 mmol/mol) (both inclusive) by central laboratory analysis.
- •5\. BMI greater than or equal to 20 kg/m2 and lesser than 40 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 well as prior insulin treatment for gestational diabetes.
- •7\. Oral antidiabetic treatment:
- •a. SGLT2i: Subjects must have been on a stable daily dose of any SGLT2i (greater than or equal to half of the maximum approved dose according to current local label or maximum tolerated dose as documented in subject medical record, or minimum recommended maintenance dose according to current local label) for at least 90 days prior to the day of screening.
- •b. Combination therapy: Stable daily dose of SGLT2i as outlined above in combination with stable daily dose(s) of metformin with/without DPP4i is allowed:
- •i. Metformin (greater than or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) for at least 90 days prior to the day of screening.
Exclusion Criteria
- •1\. Known or suspected hypersensitivity to trial product(s) or related products.
- •2\. Previous participation in this trial. Participation is defined as signed informed consent.
- •3\. Receipt of any investigational medicinal product within 90 days prior to screening.
- •4\. Female who is pregnant, breast\-feeding or intends to become pregnant or is of child\-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- •5\. Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening.
- •6\. Use of GLP\-1 receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening.
- •7\. 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.
- •8\. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroids carcinoma.
- •9\. Screening calcitonin \>\= 50 ng/L.
Outcomes
Primary Outcomes
Not specified
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