A Trial to determine the Efficacy and Safety of Oral Semaglutide versus Placebo in Subjects diagnosed with Type 2 Diabetes Mellitus treated with insulin

Phase 3

Active, not recruiting

• Conditions: Type 2 diabetes mellitus,

• Registration Number: CTRI/2017/06/008830
• Lead Sponsor: Novo Nordisk India Private Ltd

Brief Summary

This trial is conductedglobally. This is a 52-week, randomised, double-blind, placebo-controlled,four-armed, parallel-group, multicentre, multinational trial. The trial willcompare the efficacy and safety of three dose levels of once-daily oralsemaglutide versus placebo in subjects with T2DM treated with insulin. Thetotal trial duration for the individual subject will be approximately 59 weeks.The trial includes a 2-week screening period followed by a 52-week randomisedtreatment period and a 5-week follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• 1Informed 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.
• 2Male or female, age above or equal to 18 years at the time of signing informed consent.
• 3Diagnosed with type 2 diabetes mellitus ≥ 90 days prior to the day of screening.
• 4HbA1c of 7.0-9.5 percentage(53-80 mmol/mol) (both inclusive).
• 5Stable treatment with one of the following insulin regimens (minimum 10 IU/day) ≥ 90 days prior to the day of screening.
• Maximum 20% change in total daily dose is acceptable: 1Basal insulin alone 2Basal and bolus insulin in any combination 3Premixed insulin including combinations of soluble insulins 4Concomitant treatment with stable daily dose of metformin (≥ 1500 mg or maximum tolerated dose as documented in the subject medical record) ≥ 90 days prior to the day of screening is allowed.

Exclusion Criteria

• 1Known or suspected hypersensitivity to trial product(s) or related products.
• 2Previous participation in this trial.
• Participation is defined as signed informed consent.
• 3Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
• 4Receipt of any investigational medicinal product within 90 days before screening.
• 5Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
• 6Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
• 7History of pancreatitis (acute or chronic).
• 8History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
• 9Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation.
• 10Classified as being in New York Heart Association (NYHA) Class IV.
• 11Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
• 12Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
• 13Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening.
• An exception is short-term change of insulin treatment for acute illness for a total of ≤ 14 days.
• 14Known hypoglycaemic unawareness according to Clarke’s questionnaire.
• 15Proliferative retinopathy or maculopathy requiring acute treatment.
• Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
• 16History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
• 17Subjects with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Week 0 to week 26

Secondary Outcome Measures

Name	Time	Method
Change from baseline to week 26 in body weight	Week 0 to week 26
Change from baseline to week 52 in:	1HbA1c
Change from baseline to week 26 and week 52 in:	1Fasting plasma glucose (FPG)
If a subject after week 26 and week 52 achieves HbA1c 7.0% (53 mmol/mol)	Week 0 till after week 26 and week 52
Number of treatment-emergent adverse events (TEAEs) and Systamatic Hypoglycaemic episodes during exposure to trial product, assessed	up to approximately 57 weeks

Trial Locations

Locations (12)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Apollo Gleneagles Hospitals; 🇮🇳 Kolkata, WEST BENGAL, India

Dr. Jivraj Mehta Health Foundation Bakeri Medical Research Center,; 🇮🇳 Ahmadabad, GUJARAT, India

Government Medical College; 🇮🇳 Kozhikode, KERALA, India

Grand medical Foundation Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

IPGME&R and SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Madras Diabetes Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

Manipal Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Prince Aly Khan Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

SMS Medical College & Attached Hospitals; 🇮🇳 Jaipur, RAJASTHAN, India

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All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Yashdeep Gupta

Principal investigator

9999598468

yash_deep_gupta@yahoo.co.in