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Trial · Interventional

CompletedPhase 4Results postedRegistry data

The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

NCTNCT02008682 (opens ClinicalTrials.gov in a new tab)Other idNN2211-4075Other idU1111-1139-0016
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
368 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Dec 2013
Primary completion
Nov 2014
Completion
Nov 2014
First posted
11 Dec 2013 (estimated)
Last update posted
9 Mar 2017
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
201320142015
  1. Ph 4

    The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

    NCT02008682

    Dec 2013 to Nov 2014

Registry summary

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

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible subjects will continue their metformin background treatment during the trial.

Interventions

  • liraglutideDrug
  • sitagliptinDrug

Arms2

  • Experimental

    Liraglutide 1.8 mg + metformin

    2-week screening period, 26-week treatment duration, and a 1-week follow-up period

  • Active comparator

    Sitagliptin 100 mg + metformin

    2-week screening period, 26-week treatment duration, and a 1-week follow-up period

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c)

    Time frame · Week 0, week 26

    Registry description

    Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

Secondary outcomes(5)

  1. Change From Baseline in Fasting Plasma Glucose

    Time frame · Week 0, week 26

    Registry description

    Mean change from baseline in fasting plasma glucose (FPG) at Week 26.

  2. Change From Baseline in 7-point Self-measured Plasma Glucose Profile

    Time frame · Week 0, week 26

    Registry description

    Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.

  3. Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)

    Time frame · After 26 weeks of treatment

    Registry description

    Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26

  4. Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)

    Time frame · After 26 weeks of treatment

    Registry description

    Calculated as the percentage of subjects achieving treatment target of HbA1c \<= 6.5% at Week 26

  5. Number of Confirmed Hypoglycaemic Episodes

    Time frame · Weeks 0-26

    Registry description

    confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose \< 3.1 mmol/L

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 From Baseline in Glycosylated Haemoglobin (HbA1c)

GroupValue (Percent (%) glycosylated haemoglobin)Spread
Liraglutide-1.6660.9982
Sitagliptin-0.9690.9742
Secondary and other outcome results(5)
Secondary outcomeMean· Week 0, week 26

Change From Baseline in Fasting Plasma Glucose

GroupValue (mmol/L)Spread
Liraglutide-2.3472.1655
Sitagliptin-1.2052.2961
Secondary outcomeMean· Week 0, week 26

Change From Baseline in 7-point Self-measured Plasma Glucose Profile

GroupValue (mmol/L)Spread
Liraglutide-2.252.244
Sitagliptin-1.362.204
Secondary outcomeNumber· After 26 weeks of treatment

Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)

GroupValue (percentage of subjects)
Liraglutide76.5
Sitagliptin52.6
Secondary outcomeNumber· After 26 weeks of treatment

Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)

GroupValue (percentage of subjects)
Liraglutide61.7
Sitagliptin26.3
Secondary outcomeNumber· Weeks 0-26

Number of Confirmed Hypoglycaemic Episodes

GroupValue (episodes)
Liraglutide2
Sitagliptin1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutidesubcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.–3 / 18365 / 183
Sitagliptinorally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).–6 / 18414 / 184

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 · 2016

9 results

Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial.

Zang et al. 2016Diabetes, obesity & metabolismcited by 27

PMID 27060930PMC5084818DOI 10.1111/dom.12674PUB-27060930

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, age at least 18 years and below 80 years at the time of signing informed consent * Subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to 1000 mg daily for at least 60 days prior to screening * HbA1c 7.0-10.0% (both inclusive) * Body mass index below or equal to 45.0 kg/m\^2 Exclusion Criteria: * Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days prior to screening. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness * History of chronic pancreatitis or idiopathic acute pancreatitis * Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol * Screening calcitonin value above or equal to 50 ng/l * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) * Any contraindications to liraglutide, sitagliptin or metformin according to local labelling

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