Clinical trial NCT00614120: Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Official title: Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 929
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
* HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
* HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
* BMI less than 45.0 kg/m\^2

Exclusion Criteria:

* Treatment with insulin within the last 3 months prior to the trial
* Impaired liver or/and renal function
* Significant cardiovascular disease over the last 6 months
* Known retinopathy or maculopathy
* Recurrent major hypoglycaemia or hypoglycaemic unawareness

Primary outcomes:
measure: Change in Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: week 0, week 16
Secondary outcomes:
measure: Change in Body Weight
timeFrame: week 0, week 16
measure: Change in Self-measured Fasting Plasma Glucose
timeFrame: week 0, week 16
measure: 7-point Self-measured Plasma Glucose Profiles
timeFrame: week 0, 8, 12 and 16
measure: Change in Beta-cell Function
timeFrame: week 0, week 16
measure: Change in Fasting Lipid Profile
timeFrame: week 0, week 16
measure: Change in Fasting Lipid Profile, APO-B
timeFrame: week 0, week 16
measure: Hypoglycaemic Episodes
timeFrame: weeks 0-16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Chongqing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Fuzhou
country: China
facility: Novo Nordisk Investigational Site
state: Fujian
city: Harbin
country: China
facility: Novo Nordisk Investigational Site
state: Heilongjiang
city: Harbin
country: China
facility: Novo Nordisk Investigational Site
state: Heilongjiang
city: Wuhan
country: China
facility: Novo Nordisk Investigational Site
state: Hubei
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Suzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Wuxi
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Xi'an
country: China
facility: Novo Nordisk Investigational Site
state: Shaanxi
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Hangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Zhejiang
city: Shenyang
country: China
facility: Novo Nordisk Investigational Site
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
city: Wuhan
country: China
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderbad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Cochin
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Bhubaneswar
country: India
facility: Novo Nordisk Investigational Site
state: Orissa
city: Jaipur
country: India
facility: Novo Nordisk Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Madurai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Cochin
country: India
facility: Novo Nordisk Investigational Site
city: Ghaziabad
country: India
facility: Novo Nordisk Investigational Site
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Patna
country: India
facility: Novo Nordisk Investigational Site
city: Secunderabad
country: India
facility: Novo Nordisk Investigational Site
city: Trivandrum
country: India
facility: Novo Nordisk Investigational Site
city: Visakhapatnam
country: India
facility: Novo Nordisk Investigational Site
city: Goyang
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Incheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Sungnam
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452), MD, PhD
role: STUDY_DIRECTOR
References:
citation: Yang W, Chen L, Ji Q, Liu X, Ma J, Tandon N, Bhattacharyya A, Kumar A, Kim KW, Yoon KH, Bech OM, Zychma M. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*). Diabetes Obes Metab. 2011 Jan;13(1):81-8. doi: 10.1111/j.1463-1326.2010.01323.x.
citation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
citation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
citation: Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, Yang W. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015 Apr;108(1):113-9. doi: 10.1016/j.diabres.2015.01.001. Epub 2015 Jan 19.
citation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.