Trial · Interventional

CompletedPhase 2Results postedRegistry data

Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

NCTNCT02461589Other idNN9535-4191Other id2014-003196-39Other idU1111-1159-4923Other id2014

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 706 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 10 countries
United States, Austria, Canada, Czechia, Germany, Malaysia, Russia, Serbia, South Africa, United Kingdom
Start: 21 Sept 2015
Primary completion: 13 Oct 2016
Completion: 13 Oct 2016
First posted: 3 Jun 2015 (estimated)
Last update posted: 31 Jul 2019
Conditions: Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520162017

Ph 2
Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes
NCT02461589
21 Sept 2015 to 13 Oct 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

Interventions

semaglutideDrug
liraglutideDrug
placeboDrug

Arms13

Experimental
Semaglutide 0.05 mg/day
Active comparator
Liraglutide 0.3 mg/day
Placebo comparator
Placebo 50 µL
Experimental
Semaglutide 0.05/0.1 mg/day
Active comparator
Liraglutide 0.3/0.6 mg/day
Placebo comparator
Placebo 50/100 µL
Experimental
Semaglutide 0.05/0.1/0.2 mg/day
Active comparator
Liraglutide 0.3/0.6/1.2 mg/day
Placebo comparator
Placebo 50/100/200 µL
Experimental
Semaglutide 0.05/0.1/0.2/0.3 mg/day
Active comparator
Liraglutide 0.3/0.6/1.2/1.8 mg/day
Placebo comparator
Placebo 50/100/200/300 µL
Experimental
Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in HbA1c (Glycosylated Haemoglobin)
Time frame · Week 0, week 26
Registry description
Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Secondary outcomes(3)

Change in Fasting Plasma Glucose (FPG)
Time frame · Week 0, Week 26
Registry description
Estimated mean change from baseline in FPG at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Body Weight Change
Time frame · Week 0, Week 26
Registry description
The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Change in Systolic and Diastolic Blood Pressure
Time frame · Week 0, Week 26
Registry description
The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 26

Change in HbA1c (Glycosylated Haemoglobin)

Group	Value (percentage of glycosylated haemoglobin)	Spread
Semaglutide 0.05 mg/Day	-0.97	0.85
Semaglutide 0.1 mg/Day	-1.30	1.03
Semaglutide 0.2 mg/Day	-1.65	0.79
Semaglutide 0.3 mg/Day	-1.96	0.95
Liraglutide 0.3 mg/Day	-0.50	0.93
Liraglutide 0.6 mg/Day	-0.88	0.90
Liraglutide 1.2 mg/Day	-0.86	0.92
Liraglutide 1.8 mg/Day	-1.32	0.78
Placebo	-0.05	0.90
Semaglutide Flexible	-1.72	0.97

Secondary and other outcome results(3)

Secondary outcomeMean· Week 0, Week 26

Change in Fasting Plasma Glucose (FPG)

Group	Value (mmol/L)	Spread
Semaglutide 0.05 mg/Day	-2.09	1.96
Semaglutide 0.1 mg/Day	-2.08	2.23
Semaglutide 0.2 mg/Day	-2.64	2.07
Semaglutide 0.3 mg/Day	-3.53	2.20
Liraglutide 0.3 mg/Day	-1.33	2.06
Liraglutide 0.6 mg/Day	-1.56	1.74
Liraglutide 1.2 mg/Day	-1.51	2.41
Liraglutide 1.8 mg/Day	-1.92	2.34
Placebo	-0.54	2.45
Semaglutide Flexible	-3.40	2.84

Secondary outcomeMean· Week 0, Week 26

Body Weight Change

Group	Value (kg)	Spread
Semaglutide 0.05 mg/Day	-2.75	2.82
Semaglutide 0.1 mg/Day	-4.36	4.24
Semaglutide 0.2 mg/Day	-6.70	4.57
Semaglutide 0.3 mg/Day	-8.23	5.34
Liraglutide 0.3 mg/Day	-1.48	3.06
Liraglutide 0.6 mg/Day	-1.81	3.06
Liraglutide 1.2 mg/Day	-1.78	3.41
Liraglutide 1.8 mg/Day	-3.68	4.26
Placebo	-1.22	3.42
Semaglutide Flexible	-6.60	4.98

Secondary outcomeMean· Week 0, Week 26

Change in Systolic and Diastolic Blood Pressure

Group	Value (mmHg)	Spread
Semaglutide 0.05 mg/Day	-5.74	12.30
Semaglutide 0.1 mg/Day	-2.77	13.21
Semaglutide 0.2 mg/Day	-4.25	12.24
Semaglutide 0.3 mg/Day	-9.85	11.58
Liraglutide 0.3 mg/Day	-3.77	9.79
Liraglutide 0.6 mg/Day	-3.20	10.89
Liraglutide 1.2 mg/Day	-4.69	12.73
Liraglutide 1.8 mg/Day	-2.99	11.94
Placebo	-2.34	11.40
Semaglutide Flexible	-6.62	14.02

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Semaglutide 0.05 mg/DayParticipants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	7 / 64	31 / 64
Semaglutide 0.1 mg/DayParticipants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	3 / 63	34 / 63
Semaglutide 0.2 mg/DayParticipants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	2 / 65	39 / 65
Semaglutide 0.3 mg/DayParticipants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	2 / 63	42 / 63
Liraglutide 0.3 mg/DayParticipants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	1 / 64	33 / 64
Liraglutide 0.6 mg/DayParticipants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	2 / 64	27 / 64
Liraglutide 1.2 mg/DayParticipants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	2 / 64	35 / 64
Liraglutide 1.8 mg/DayParticipants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	7 / 65	35 / 65
PlaceboParticipants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals.	–	0 / 129	0 / 129
Semaglutide FlexibleParticipants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment.	–	4 / 64	44 / 64

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

7 results

A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin.

Lingvay et al. 2018Diabetes carecited by 58

PMID 30026333DOI 10.2337/dc17-2381PUB-30026333

Full text at the publisher7 results

Publisher page See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female, age at least 18 years at the time of signing informed consent. * Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening * HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive) * BMI: 25.0 - 40.0 kg/m\^2 (both inclusive) Exclusion Criteria: * Simultaneous participation in any other clinical trial of an investigational medicinal product * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) * 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 screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days) * Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids) * History of pancreatitis (acute or chronic) * Screening calcitonin above or equal to 50 ng/L * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC) * Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology) * Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack * Currently planned coronary, carotid or peripheral artery revascularisation * Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

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