AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 2NCT00290940

Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

A Phase 2 study testing CS-917, metformin hydrochloride and pioglitazone in people with Diabetes Mellitus, Type 2, run by Daiichi Sankyo at 66 sites in United States.

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 study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
CS-917, metformin hydrochloride and pioglitazone
How many people
400 participants
Where
66 sitesUnited States
Study dates
Jan 2006to Apr 2007
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Drug naive or newly diagnosed type 2 diabetic subjects:
  • Never received oral antihyperglycemic or insulin therapy or
  • No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
  • No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
  • No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
  • HbA1C>6.7% and < or = to 10% at screening

Who cannot join

  • Current insulin therapy
  • Symptoms of poorly controlled diabetes
  • History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
  • Serum bicarbonate < or = to 19 meq/L
  • Serum creatinine (Scr) > 1.4 mg/dL (females) or 1.5 mg/dL (males)
  • Contraindication to metformin

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Brooksville, Florida, 34613

  • Study site

    Burke, Virginia

  • Study site

    Cadillac, Michigan, 49601

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina, 28262

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Corpus Christi, Texas, 78404

  • Study site

    Cudahy, California, 90201

  • Study site

    Delaware, Ohio, 43015

  • Study site

    Detroit, Michigan, 48235

  • Study site

    Elizabeth, New Jersey, 07202

  • Study site

    Excelsior Springs, Missouri, 64024

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Greer, South Carolina

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Houston, Texas, 77024

  • Study site

    Interlochen, Michigan, 49643

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Lake Jackson, Texas, 77566

  • Study site

    Las Vegas, Nevada, 89103

  • Study site

    Lenoir, North Carolina, 28645

  • Study site

    Livonia, Michigan, 48152

  • Study site

    Long Beach, California, 90806

  • Study site

    Madison, Wisconsin, 53719

  • Study site

    Marion, Ohio, 43302

  • Study site

    Mesa, Arizona, 85201

  • Study site

    Miami, Florida, 33156

  • Study site

    Nashville, Tennessee

  • Study site

    North Richland Hills, Texas

  • Study site

    Northport, Alabama, 35476

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Olympia, Washington, 98502

  • Study site

    Oxon Hill, Maryland, 20745

  • Study site

    Pembroke Pines, Florida, 33028

  • Study site

    Phoenix, Arizona, 85014

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Port Gibson, Mississippi, 39150

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Reading, Pennsylvania, 19696

  • Study site

    Rolling Fork, Mississippi, 39159

  • Study site

    Rome, Georgia

  • Study site

    Roseville, California, 95661

  • Study site

    Sacramento, California, 95841

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Sebastian, Florida

  • Study site

    Shawnee Mission, Kansas, 66216

  • Study site

    Spring Valley, California, 91978

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Studio City, California, 91604

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Tempe, Arizona, 85282

  • Study site

    Toms River, New Jersey, 08755

  • Study site

    Topeka, Kansas, 66614

  • Study site

    Topeka, Kansas

  • Study site

    Vista, California, 92083

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Warner Robins, Georgia, 31093

  • Study site

    West Hills, California, 91307

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Wilmington, Delaware, 19805

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CS-917 as Monotherapy for Type 2 Diabetes

This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment

Being tested
CS-917, metformin hydrochloride, pioglitazone
Keywords
Diabetes mellitus, Type 2, High blood sugar, Hyperglycemia, Antihyperglycemic agents, CS-917
Medical subject headings
Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

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

What is being measured

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

  1. Mean change from baseline in HbA1C after 12 weeks compared to placebo

Secondary outcomes (5)

  1. Onset of efficacy of CS-917

  2. Safety and tolerability of CS-917

  3. Changes in other relevant glycemic and metabolic measures

  4. Proportion of subjects achieving therapeutic response

  5. Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia

Timeline

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

  1. First posted13 Feb 2006 (estimated)
  2. Study startJan 2006
  3. Study completionApr 2007

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290940
Sponsor's protocol ID
CS0917-A-U205
Status last verified
Sep 2007
First submitted
10 Feb 2006
Last updated
11 Sep 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CS-917, metformin hydrochloride and pioglitazone in people with Diabetes Mellitus, Type 2, run by Daiichi Sankyo at 66 sites in United States.

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 6 inclusion and 6 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 11 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Mean change from baseline in HbA1C after 12 weeks compared to placebo. 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 NCT00290940.

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 11 Sep 2007.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in