Efficacy and Safety of Oral Semaglutide versus Placebo in Subjects with Type 2 Diabetes Mellitus treated with insuli
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-000988-16-GR
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 590
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 above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age above or equal to 20 years at the time of signing informed consent.
3. Diagnosed with type 2 diabetes mellitus = 90 days prior to the day of screening.
4. HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
5. Stable 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:
- Basal insulin alone
- Basal and bolus insulin in any combination
- Premixed insulin including combinations of soluble insulins
Concomitant 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. For Japan only: Concomitant treatment with metformin is only allowed in combination with basal insulin alone (not in combination with basal-bolus or premixed insulin including combinations of soluble insulins).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240
1. Female 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). For Greece only: adequate contraceptive measures are defined as combined hormonal contraception (containing oestrogen and progesterone), which suppress ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception which suppress ovulation (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy, sexual abstinence. For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives.
2. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
3. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary
Thyroid Carcinoma (MTC).
4. History of pancreatitis (acute or chronic).
5. History 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).
6. Any 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.
7. Classified as being in New York Heart Association (NYHA) Class IV.
8. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
9. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
10. Treatment 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.
11. Known hypoglycaemic unawareness according to Clarke’s questionnaire.
12. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or dilated fundoscopy performed within 90 days prior to randomisation.
13. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
14. Subjects with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg)<br>versus placebo on glycaemic control in subjects with type 2 diabetes mellitus treated with insulin.;Secondary Objective: 1. To compare the effect of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg) versus placebo on body weight in subjects with type 2 diabetes mellitus treated with insulin.<br>2. To compare the safety and tolerability of once-daily dosing of three dose levels of oral semaglutide<br>(3, 7 and 14 mg) versus placebo in subjects with type 2 diabetes mellitus treated with insulin.;Primary end point(s): 1. Change in HbA1c;Timepoint(s) of evaluation of this end point: 1. From baseline to week 26
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in body weight (kg)<br>2. Change in HbA1c<br>3. Change in Body weight (kg)<br>4. Change in Fasting plasma glucose (FPG)<br>5. If a subject achieves (yes/no): HbA1c < 7.0% (53 mmol/mol) (American Diabetes Association (ADA) target)<br>6. Number of treatment-emergent adverse events (TEAEs) during exposure to trial product<br>7. Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic<br>episodes during exposure to trial product;Timepoint(s) of evaluation of this end point: 1. From baseline to week 26<br>2. From baseline to week 52<br>3. From baseline to week 52<br>4. From baseline to week 26 and week 52<br>5. After week 26 and week 52 <br>6. Assessed up to approximately 57 weeks<br>7. Assessed up to approximately 57 weeks<br>