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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.

NCTNCT02505334 (opens ClinicalTrials.gov in a new tab)Other idNN2211-4174Other idU1111-1164-5462Other idJapicCTI-152975
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
635 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
21 Jul 2015
Primary completion
2 May 2017
Completion
9 Nov 2017
First posted
22 Jul 2015 (estimated)
Last update posted
5 Sept 2018
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
2015201620172018
  1. Ph 3

    A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.

    NCT02505334

    21 Jul 2015 to 9 Nov 2017

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 the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.

Interventions

  • liraglutideDrug

Arms2

  • Experimental

    Liraglutide 1.8 mg

    The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.

  • Active comparator

    Liraglutide 0.9 mg

    The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Haemoglobin (HbA1c) (Week 26)

    Time frame · Week 0, Week 26

    Registry description

    Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.

Secondary outcomes(20)

  1. Change in HbA1c (Week 52)

    Time frame · Week 0, Week 52

    Registry description

    Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.

  2. Responder for HbA1c Below 7.0% (53 mmol/Mol)

    Time frame · Week 26 and Week 52

    Registry description

    Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.

  3. Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)

    Time frame · Week 26 and Week 52

    Registry description

    Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.

  4. Responder for HbA1c Below 7.0% Without Weight Gain

    Time frame · Week 26 and Week 52

    Registry description

    Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.

  5. Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

    Time frame · Week 26 and Week 52

    Registry description

    Reported results are subjects with HbA1c \<7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'

  6. Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)

    Time frame · Week 0 and Week 26 and Week 52

    Registry description

    Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first: 1. Before breakfast. 2. 90 minutes after start of breakfast. 3. Before lunch. 4. 90 minutes after start of lunch. 5. Before dinner. 6. 90 minutes after start of dinner. 7. At bedtime.

  7. Change in SMBG 7-point Profile: Mean of 7-point Profile

    Time frame · Week 0, Week 26, Week 52

    Registry description

    Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  8. Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)

    Time frame · Week 0, Week 26, Week 52

    Registry description

    Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  9. Change in Fasting Plasma Glucose (FPG)

    Time frame · Week 0, Week 26, Week 52

    Registry description

    Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  10. Change in Waist Circumference

    Time frame · Week 0, Week 26, Week 52

    Registry description

    Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  11. Change in Body Weight

    Time frame · Week 0, Week 26, Week 52

    Registry description

    Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  12. Change in Body Mass Index (BMI)

    Time frame · Week 0, Week 26, Week 52

    Registry description

    Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  13. Change in Blood Pressure (Systolic and Diastolic)

    Time frame · Week 0, Week 26, Week 52

    Registry description

    Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  14. Fasting C-peptide

    Time frame · Week 26 and Week 52

    Registry description

    Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  15. Fasting Insulin

    Time frame · Week 26 and Week 52

    Registry description

    Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  16. Fasting Glucagon

    Time frame · Week 26 and Week 52

    Registry description

    Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  17. Proinsulin

    Time frame · Week 26 and Week 52

    Registry description

    Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  18. Proinsulin/Insulin

    Time frame · Week 26 and Week 52

    Registry description

    Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.

  19. Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

    Time frame · Week 26 and Week 52

    Registry description

    HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=\[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)\].

  20. Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

    Time frame · Week 26 and Week 52

    Registry description

    HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.

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 outcomeLeast squares mean· Week 0, Week 26

Change in Glycosylated Haemoglobin (HbA1c) (Week 26)

GroupValue (Percentage (%) of HbA1c)Spread
Liraglutide 1.8 mg-0.230.06
Liraglutide 0.9 mg0.170.06
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, Week 52

Change in HbA1c (Week 52)

GroupValue (Percentage (%) of HbA1c)Spread
Liraglutide 1.8 mg8.141.02
Secondary outcomeCount of participants· Week 26 and Week 52

Responder for HbA1c Below 7.0% (53 mmol/Mol)

GroupValue (Participants)
Liraglutide 1.8 mg53
Liraglutide 0.9 mg18
Secondary outcomeCount of participants· Week 26 and Week 52

Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)

GroupValue (Participants)
Liraglutide 1.8 mg18
Liraglutide 0.9 mg5
Secondary outcomeCount of participants· Week 26 and Week 52

Responder for HbA1c Below 7.0% Without Weight Gain

GroupValue (Participants)
Liraglutide 1.8 mg36
Liraglutide 0.9 mg13
Secondary outcomeCount of participants· Week 26 and Week 52

Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

GroupValue (Participants)
Liraglutide 1.8 mg53
Liraglutide 0.9 mg18
Secondary outcomeMean· Week 0 and Week 26 and Week 52

Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)

GroupValue (mg/dL)Spread
Liraglutide 1.8 mg181.842.8
Liraglutide 0.9 mg177.143.4
Secondary outcomeMean· Week 0, Week 26, Week 52

Change in SMBG 7-point Profile: Mean of 7-point Profile

GroupValue (mg/dL)Spread
Liraglutide 1.8 mg217.946.7
Liraglutide 0.9 mg217.746.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide 1.8 mgSubjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.0 / 2338 / 23399 / 233
Liraglutide 0.9 mgSubjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.0 / 2333 / 23365 / 233

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female Japanese subjects at least 20 years of age at the time of informed consent * Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening * HbA1c 7.5-10.0% \[58 mmol/mol-86 mmol/mol\] (both inclusive) * Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling Exclusion Criteria: * Treatment with insulin within 12 weeks prior to screening * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening * Screening calcitonin equal or above 50 ng/l * History of pancreatitis (acute or chronic) * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) * Subjects presently classified as being in New York Heart Association (NYHA) Class IV * Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack * Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas) * Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol

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