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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/06/008830
• Date of registration: 14-06-2017
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk India Private Ltd
• Public title: A Trial to determine the Efficacy and Safety of Oral Semaglutide versus Placebo in Subjects diagnosed with Type 2 Diabetes Mellitus treated with insulin
• Scientific title: "Efficacy and Safety of Oral Semaglutide versus Placebo in Subjects with Type 2 Diabetes Mellitus treated with insulin"
• Date of first enrolment: 15-06-2017
• Target sample size: 720
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16727
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Canada, France, Greece, India, Japan, Mexico, Poland, Russian Federation, United States of America

Contacts

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

Key inclusion & exclusion criteria

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 investigatorâ??s opinion might jeopardise subjectâ??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 Clarkeâ??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).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Type 2 Diabetes Health Condition 2: E11- Type 2 diabetes mellitus

Intervention(s)

Intervention1: Oral Semaglutide
: Once daily dose of 3mg, 7mg and 14mg of oral semaglutide
Total duration 52 week
Control Intervention1: Placebo: Once daily dose of 3mg, 7mg and 14mg of placebo orally
Total duration 52 week

Primary Outcome(s)

Change from baseline in HbA1c

Timepoint: Week 0 to week 26

Secondary Outcome(s)

Number of treatment-emergent adverse events (TEAEs) and Systamatic Hypoglycaemic episodes during exposure to trial product, assessed

up to approximately 57 weeksTimepoint: Week 0 to week 57

Change from baseline to week 26 and week 52 in:

1Fasting plasma glucose (FPG)Timepoint: Week 0 to week 26 and week 52

Change from baseline to week 52 in:

1HbA1c

2Body weight (kg)Timepoint: Week 0 to week 52

If a subject after week 26 and week 52 achieves HbA1c 7.0% (53 mmol/mol)Timepoint: Week 0 till after week 26 and week 52

Change from baseline to week 26 in body weightTimepoint: Week 0 to week 26

Secondary ID(s)

NN9924-4280, Amendment No -2,version -3.0, dated 22 Nov 2016

1111-1180-3637

Source(s) of Monetary Support

Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066, India

Ethics review

Status: Approved
Approval date: 10/02/2017
Contact:

Institutional Ethics Committee, AIIMS

Status: Approved
Approval date: 27/02/2017
Contact:

Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Center Institutional Ethics committee

Status: Approved
Approval date: 02/03/2017
Contact:

Institutional Ethics Committee, Madras Diabetes Research Foundation

Status: Approved
Approval date: 20/03/2017
Contact:

Ethics Committee of Manipal Hospitals

Status: Approved
Approval date: 30/03/2017
Contact:

Institutional Ethics Committee, IPGME&R and SSKM Hospital

Status: Approved
Approval date: 08/04/2017
Contact:

Institutional Ethics committee, Apollo Gleneagles Hospitals

Status: Approved
Approval date: 08/04/2017
Contact:

Prince Aly Khan hospital Institutional Ethics Committee

Status: Approved
Approval date: 05/05/2017
Contact:

Institutional Ethics Committee, Govt. Medical College

Status: Approved
Approval date: 16/06/2017
Contact:

Ethics Committee of Diabetes Thyroid hormone research institute

Status: Approved
Approval date: 12/02/2018
Contact:

Institutional Ethics Committee Poona Medical Research Foundation

Status: Not Applicable
Approval date:
Contact:

The Ethics Committee, S.M.S Hospital