DiabetesPhase 3NCT00399711

Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

A Phase 3 study testing repaglinide and metformin combination tablet and rosiglitazone and metformin combination tablet in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 103 sites in 2 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 the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: repaglinide and metformin combination tablet and rosiglitazone and metformin combination tablet
Type of treatment: Pill or oral medicine
How many people: 560 participants
Where: 103 sitesin 2 countries
Study dates: Nov 2006to Nov 2007
Phase: Phase 3
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes for at least 3 months
HbA1c between 7.5-11.0% on monotherapy or
HbA1c between 7.0-10.0% on dual therapy
BMI maximum 45 kg/m2

Who cannot join

Any clinically significant disease history in the opinion of the investigator
Severe heart disease
Pregnancy

Trial locations and contacts

103 sites in 2 countries.

Country

City, postcode or hospital

103 sites in 2 countries

United States102 sites

Novo Nordisk Investigational Site
Ann Arbor, Michigan, 48106
Novo Nordisk Investigational Site
Arlington Heights, Illinois, 60004
Novo Nordisk Investigational Site
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Aurora, Illinois, 60504
Novo Nordisk Investigational Site
Aventura, Florida, 33180
Novo Nordisk Investigational Site
Baltimore, Maryland, 21209
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Bossier City, Louisiana, 71111
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, 60616
Novo Nordisk Investigational Site
Chula Vista, California, 91911
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80904
Novo Nordisk Investigational Site
Columbus, Georgia, 31904
Novo Nordisk Investigational Site
Corpus Christi, Texas, 78412
Novo Nordisk Investigational Site
Cranston, Rhode Island, 02920
Novo Nordisk Investigational Site
Dallas, Texas, 75224
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858
Novo Nordisk Investigational Site
Daytona Beach, Florida, 32117
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314
Novo Nordisk Investigational Site
East Providence, Rhode Island, 02914
Novo Nordisk Investigational Site
Erlanger, Kentucky, 41018
Novo Nordisk Investigational Site
Flint, Michigan, 48504
Novo Nordisk Investigational Site
Flossmoor, Illinois, 60422
Novo Nordisk Investigational Site
Franklin, Ohio, 45005
Novo Nordisk Investigational Site
Glendale, Arizona, 85306
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hamden, Connecticut, 06518
Novo Nordisk Investigational Site
Henrico, Virginia, 23233
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46250
Novo Nordisk Investigational Site
Inverness, Florida, 34452
Novo Nordisk Investigational Site
Jacksonville, Florida, 32116
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, 32259
Novo Nordisk Investigational Site
Jersey City, New Jersey, 07306
Novo Nordisk Investigational Site
Jonesboro, Arkansas, 72401
Novo Nordisk Investigational Site
Kansas City, Missouri, 64111
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Knoxville, Tennessee, 37920
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89102
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89123
Novo Nordisk Investigational Site
Lebanon, Virginia, 24266
Novo Nordisk Investigational Site
Long Beach, California, 90807
Novo Nordisk Investigational Site
Longwood, Florida, 32779
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Louisville, Kentucky, 40213
Novo Nordisk Investigational Site
Marietta, Georgia, 30066
Novo Nordisk Investigational Site
Mesa, Arizona, 85206
Novo Nordisk Investigational Site
Midland, Texas, 79707
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Mt. Pleasant, South Carolina, 29464
Novo Nordisk Investigational Site
Nampa, Idaho, 83687
Novo Nordisk Investigational Site
Naperville, Illinois, 60564
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Oak Brook, Illinois, 60523
Novo Nordisk Investigational Site
Oak Park, Michigan, 48237
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Orlando, Florida, 32804
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19152
Novo Nordisk Investigational Site
Plano, Texas, 75093
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Portland, Oregon, 97220
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27609
Novo Nordisk Investigational Site
Redlands, California, 92374
Novo Nordisk Investigational Site
Richmond, Virginia, 23229
Novo Nordisk Investigational Site
Rochester, New York, 14609
Novo Nordisk Investigational Site
Sacramento, California, 95825
Novo Nordisk Investigational Site
Salisbury, North Carolina, 28144
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Diego, California, 92121
Novo Nordisk Investigational Site
San Diego, California, 92128
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, 66204
Novo Nordisk Investigational Site
Simpsonville, South Carolina, 29681-1538
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
Springfield, Pennsylvania, 19064-2527
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Stamford, Connecticut, 06905
Novo Nordisk Investigational Site
Tampa, Florida, 33603
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Troy, Michigan, 48098
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74104
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74136
Novo Nordisk Investigational Site
Vernon Hills, Illinois, 60061
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
Virginia Beach, Virginia, 23454
Novo Nordisk Investigational Site
Warren Township, New Jersey, 07059
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico1 site

Novo Nordisk Investigational Site
San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: repaglinide and metformin combination tablet, rosiglitazone and metformin combination tablet
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.

repaglinide and metformin combination tabletDrug
rosiglitazone and metformin combination tabletDrug

What is being measured

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

HbA1c
Measured: After 26 weeks of treatment

Secondary outcomes (8)

Change in 8-point Glucose Profiles
Change in Lipid Profile
Events of hypoglycemia
Safety parameters
Change in Fasting Plasma Glucose
Waist/hip ratio change
Change in body weight
Percentage of subjects achieving sudden levels of HbA1c

Timeline

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

Nov 2006Nov 2007

First posted15 Nov 2006 (estimated)
Study startNov 2006
Primary completionNov 2007
Study completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: None (open label)
Enrolment: 560 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00399711
Sponsor's protocol ID: NN4440-1794
Status last verified: Feb 2017
First submitted: 14 Nov 2006
Last updated: 10 Feb 2017
Results posted: No
Data monitoring committee: No

Publications

Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily and three-times-daily dosing of a repaglinide/metformin fixed-dose combination tablet provide similar glycaemic control. Diabetes Obes Metab. 2009 Oct;11(10):947-52. doi: 10.1111/j.1463-1326.2009.01069.x. Epub 2009 Jun 16.
PubMed 19531054
Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet. Diabetes Obes Metab. 2009 Sep;11(9):865-73. doi: 10.1111/j.1463-1326.2009.01062.x. Epub 2009 May 19.
PubMed 19476470

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 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety
ClinicalTrials.gov ID: NCT00399711
Acronym / sponsor ID: NN4440-1794
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 560 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 15 Nov 2006 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

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

Key inclusion criteria (4 listed)

Type 2 diabetes for at least 3 months
HbA1c between 7.5-11.0% on monotherapy or
HbA1c between 7.0-10.0% on dual therapy
BMI maximum 45 kg/m2

Key exclusion criteria (3 listed)

Any clinically significant disease history in the opinion of the investigator
Severe heart disease
Pregnancy

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
repaglinide and metformin combination tablet	Drug	–
rosiglitazone and metformin combination tablet	Drug	–

Primary outcome

HbA1c
Time frame: After 26 weeks of treatment

8 secondary outcomes

Change in 8-point Glucose Profiles
Change in Lipid Profile
Events of hypoglycemia
Safety parameters
Change in Fasting Plasma Glucose
Waist/hip ratio change
Change in body weight
Percentage of subjects achieving sudden levels of HbA1c

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Results publication: PubMed 19531054Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily and three-times-daily dosing of a repaglinide/metformin fixed-dose combination tablet provide similar glycaemic control. Diabetes Obes Metab. 2009 Oct;11(10):947-52. doi: 10.1111/j.1463-1326.2009.01069.x. Epub 2009 Jun 16.
Results publication: PubMed 19476470Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet. Diabetes Obes Metab. 2009 Sep;11(9):865-73. doi: 10.1111/j.1463-1326.2009.01062.x. Epub 2009 May 19.
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 study director

Novo Nordisk A/S

103 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 3 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Puerto Rico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1c (time frame: After 26 weeks of treatment). 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 NCT00399711, which also lists 2 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 10 Feb 2017.