DiabetesPhase 3NCT00614120

Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

A Phase 3 study testing liraglutide, glimepiride and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 50 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: liraglutide, glimepiride and metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 929 participants
Where: 50 sitesin 3 countries
Study dates: Jan 2008to Feb 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

50 sites in 3 countries.

Country

City, postcode or hospital

50 sites in 3 countries

India24 sites

Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380 015
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560 017
Novo Nordisk Investigational Site
Bhubaneswar, Odisha, 751019
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600 013
Novo Nordisk Investigational Site
Ghaziabad
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500 001
Novo Nordisk Investigational Site
Hyderbad, Andhra Pradesh, 500 012
Novo Nordisk Investigational Site
Jaipur, Rajasthan, 302006
Novo Nordisk Investigational Site
Kochi, Kerala, 695010
Novo Nordisk Investigational Site
Kochi, 682 304
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700054
Novo Nordisk Investigational Site
Kolkata, 700017
Novo Nordisk Investigational Site
Kolkata, 700026
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, 625 020
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400010
Novo Nordisk Investigational Site
Mumbai, 400 0067
Novo Nordisk Investigational Site
Mumbai, 400016
Novo Nordisk Investigational Site
New Dehli, New Delhi, 110029
Novo Nordisk Investigational Site
New Delhi, 110017
Novo Nordisk Investigational Site
Patna, 800020
Novo Nordisk Investigational Site
Pune, Maharashtra, 411 037
Novo Nordisk Investigational Site
Secunderabad, 500 003
Novo Nordisk Investigational Site
Trivandrum, 695029
Novo Nordisk Investigational Site
Visakhapatnam, 530002

Other trials in India

China16 sites

Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100029
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100730
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, 400010
Novo Nordisk Investigational Site
Fuzhou, Fujian, 350025
Novo Nordisk Investigational Site
Hangzhou, Zhejiang, 310003
Novo Nordisk Investigational Site
Harbin, Heilongjiang, 150001
Novo Nordisk Investigational Site
Harbin, Heilongjiang, 150086
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210008
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200003
Novo Nordisk Investigational Site
Shenyang, 110001
Novo Nordisk Investigational Site
Suzhou, Jiangsu, 215004
Novo Nordisk Investigational Site
Tianjin, 300052
Novo Nordisk Investigational Site
Wuhan, Hubei, 430022
Novo Nordisk Investigational Site
Wuhan, 430060
Novo Nordisk Investigational Site
Wuxi, Jiangsu, 214023
Novo Nordisk Investigational Site
Xi'an, Shaanxi, 710032

Other trials in China

South Korea10 sites

Novo Nordisk Investigational Site
Goyang, 410-719
Novo Nordisk Investigational Site
Incheon, 405-220
Novo Nordisk Investigational Site
Seoul, 03080
Novo Nordisk Investigational Site
Seoul, 08308
Novo Nordisk Investigational Site
Seoul, 130-872
Novo Nordisk Investigational Site
Seoul, 135-710
Novo Nordisk Investigational Site
Seoul, 137-701
Novo Nordisk Investigational Site
Seoul, 150-713
Novo Nordisk Investigational Site
Sungnam, 463-707
Novo Nordisk Investigational Site
Suwon, 16499

Other trials in South Korea

About this study

Official title: Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes

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

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: liraglutide, placebo, glimepiride, metformin
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liraglutideDrug
0.6 mg/day, s.c. (under the skin) injection
placeboDrug
Glimepiride placebo, capsules
liraglutideDrug
1.2 mg/day, s.c. (under the skin) injection
liraglutideDrug
1.8 mg/day, s.c. (under the skin) injection
glimepirideDrug
Capsules, 4.0 mg/day
metforminDrug
Tablets, 1.5-2.0 g/day
placeboDrug
Liraglutide placebo, s.c. (under the skin) injection

Study groups in NCT00614120
Study group	Role	What they receive
Lira 0.6 + Met	Experimental	Liraglutide 0.6 mg + metformin + glimepiride placebo Receives: Drug: liraglutide; Drug: placebo; Drug: metformin
Lira 1.2 + Met	Experimental	Liraglutide 1.2 mg + metformin + glimepiride placebo Receives: Drug: placebo; Drug: liraglutide; Drug: metformin
Lira 1.8 + Met	Experimental	Liraglutide + metformin + glimepiride placebo Receives: Drug: placebo; Drug: liraglutide; Drug: metformin
Glim + Met	Experimental	Glimepiride 4.0 mg + metformin + liraglutide placebo Receives: Drug: glimepiride; Drug: metformin; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycosylated Haemoglobin A1c (HbA1c)
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).
Measured: week 0, week 16

Secondary outcomes (7)

Change in Body Weight
Change in body weight from baseline (week 0) to 16 weeks (end of treatment)
Measured: week 0, week 16
Change in Self-measured Fasting Plasma Glucose
Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.
Measured: week 0, week 16
7-point Self-measured Plasma Glucose Profiles
Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).
Measured: week 0, 8, 12 and 16
Change in Beta-cell Function
Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
Measured: week 0, week 16
Change in Fasting Lipid Profile
Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:
- Total Cholesterol (TC)
- Low-density Lipoprotein-cholesterol (LDL-C)
- Very Low-density Lipoprotein-cholesterol (VLDL-C)
- High-density Lipoprotein-cholesterol (HDL-C)
- Triglyceride (TG)
- Free Fatty Acid (FFA)
Measured: week 0, week 16
Change in Fasting Lipid Profile, APO-B
Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).
Measured: week 0, week 16
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: weeks 0-16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Feb 2009

First posted13 Feb 2008 (estimated)
Study startJan 2008
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 929 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00614120
Sponsor's protocol ID: NN2211-1796
Status last verified: Jan 2017
First submitted: 15 Jan 2008
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21114607
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.
PubMed 23010561
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.
PubMed 25504028
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.
PubMed 25684604
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.
PubMed 21450987

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00614120
Acronym / sponsor ID: NN2211-1796
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 929 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Posted 12 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Lira 0.6 + Met	Experimental	Drug: liraglutide, Drug: placebo, Drug: metforminLiraglutide 0.6 mg + metformin + glimepiride placebo
Lira 1.2 + Met	Experimental	Drug: placebo, Drug: liraglutide, Drug: metforminLiraglutide 1.2 mg + metformin + glimepiride placebo
Lira 1.8 + Met	Experimental	Drug: placebo, Drug: liraglutide, Drug: metforminLiraglutide + metformin + glimepiride placebo
Glim + Met	Experimental	Drug: glimepiride, Drug: metformin, Drug: placeboGlimepiride 4.0 mg + metformin + liraglutide placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutide0.6 mg/day, s.c. (under the skin) injection	Drug	Lira 0.6 + Met
placeboGlimepiride placebo, capsules	Drug	Lira 0.6 + Met, Lira 1.2 + Met, Lira 1.8 + Met
liraglutide1.2 mg/day, s.c. (under the skin) injection	Drug	Lira 1.2 + Met
liraglutide1.8 mg/day, s.c. (under the skin) injection	Drug	Lira 1.8 + Met
glimepirideCapsules, 4.0 mg/day	Drug	Glim + Met
metforminTablets, 1.5-2.0 g/day	Drug	Glim + Met, Lira 0.6 + Met, Lira 1.2 + Met, Lira 1.8 + Met
placeboLiraglutide placebo, s.c. (under the skin) injection	Drug	Glim + Met

Primary outcome

Change in Glycosylated Haemoglobin A1c (HbA1c)
Time frame: week 0, week 16
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).

7 secondary outcomes

Change in Body Weight
Time frame: week 0, week 16
Change in Self-measured Fasting Plasma Glucose
Time frame: week 0, week 16
7-point Self-measured Plasma Glucose Profiles
Time frame: week 0, 8, 12 and 16
Change in Beta-cell Function
Time frame: week 0, week 16
Change in Fasting Lipid Profile
Time frame: week 0, week 16
Change in Fasting Lipid Profile, APO-B
Time frame: week 0, week 16
Hypoglycaemic Episodes
Time frame: weeks 0-16

Results and safety

Results posted to the registry on 12 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lira 0.6 + Met	231	202
Lira 1.2 + Met	233	187
Lira 1.8 + Met	234	175
Glim + Met	231	215

Primary outcome: Change in Glycosylated Haemoglobin A1c (HbA1c)

Time frame: week 0, week 16. Mean (Standard Deviation). Unit: percentage point of total HbA1c

Measure	Lira 0.6 + Met n = 226	Lira 1.2 + Met n = 222	Lira 1.8 + Met n = 221	Glim + Met n = 230
Value	-1.0 (1.04)	-1.3 (1.09)	-1.4 (1.23)	-1.3 (0.98)

Lira 1.8 + Met vs Glim + Met: Estimated treatment difference, LS Mean: -0.06 (95% CI -0.23 to 0.11), p <0.0001, ANCOVA
Lira 1.2 + Met vs Glim + Met: Estimated treatment difference, LS Mean: 0.03 (95% CI -0.14 to 0.20), p <.0001, ANCOVA
Lira 0.6 + Met vs Glim + Met: Estimated treatment difference, LS Mean: 0.25 (95% CI 0.08 to 0.42), p = 0.0421, ANCOVA

Population analysed: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected over a time span of 16 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lira 0.6 + Met	4 of 231 (1.7%)	67 of 231 (29%)	Not reported
Lira 1.2 + Met	8 of 233 (3.4%)	98 of 233 (42.1%)	Not reported
Lira 1.8 + Met	4 of 233 (1.7%)	113 of 233 (48.5%)	Not reported
Glim + Met	4 of 231 (1.7%)	30 of 231 (13%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21114607Yang 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.
Results publication: PubMed 23010561Alves 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.
Results publication: PubMed 25504028Jensen 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.
Results publication: PubMed 25684604Ingwersen 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.
Derived from this study: PubMed 21450987Buse 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452), MD, PhD study director

Novo Nordisk A/S

50 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide, glimepiride and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 50 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in India, China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Haemoglobin A1c (HbA1c) (time frame: week 0, week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00614120, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.