Type 2 DiabetesPhase 4NCT00402909
Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone
A Phase 4 study testing Nateglinide in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Nateglinide
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2007
- Phase
- Phase 4
- 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 78 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male/female, age 18-78 inclusive
- Type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
- HbA1c 7.0-8.5% inclusive
- Fasting plasma glucose <240 mg/dL at screening
- Body Mass Index 22-41 kg/m2
Who cannot join
- Pregnant or nursing
- Other investigational drugs within 30 days of screening
- Treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
- History of type 1 diabetes
- Abnormal kidney function
- History of acute diabetic complications
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- Congestive heart failure requiring treatment
- Myocardial infarction, coronary artery surgery, stroke within 6 months of screening
- Liver disease, liver enzymes more than 3 times upper limit of normal
- Fasting triglycerides >700 mg/dL within past 12 weeks
- Acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
- Treatment with corticosteroids
- Blood donation within past 12 weeks
- Other protocol-defined inclusion/exclusion criterial may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07974
About this study
Official title: A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Compare the Safety and Efficacy of Nateglinide vs. Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Basal Insulin Glargine in Combination With Metformin and/or Thiazolidinedione (Pioglitazone or Rosiglitazone)
This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.
- Conditions
- Type 2 Diabetes
- Being tested
- Nateglinide
- Keywords
- Type 2 diabetes,, fasting glucose,, postprandial glucose,, blood sugar,, HbA1c,, insulin,, glargine,, metformin,, thiazolidinedione
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NateglinideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin (Hb)_A1c
Secondary outcomes (3)
Change from baseline in 2-hour postprandial glucose during standardized meal test
Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%
Proportion of patients achieving reduction in HbA1c of 0.5%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402909
- Sponsor's protocol ID
- CDJN608AUS13
- Status last verified
- Feb 2017
- First submitted
- 20 Nov 2006
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Compare the Safety and Efficacy of Nateglinide vs. Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Basal Insulin Glargine in Combination With Metformin and/or Thiazolidinedione (Pioglitazone or Rosiglitazone)
- ClinicalTrials.gov ID
- NCT00402909
- Acronym / sponsor ID
- CDJN608AUS13
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes,, fasting glucose,, postprandial glucose,, blood sugar,, HbA1c,, insulin,, glargine,, metformin,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 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.
This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male/female, age 18-78 inclusive
- Type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
- HbA1c 7.0-8.5% inclusive
- Fasting plasma glucose <240 mg/dL at screening
- Body Mass Index 22-41 kg/m2
Key exclusion criteria (14 listed)
- Pregnant or nursing
- Other investigational drugs within 30 days of screening
- Treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
- History of type 1 diabetes
- Abnormal kidney function
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 |
|---|---|---|
| Nateglinide | Drug | – |
Primary outcome
Change from baseline in hemoglobin (Hb)_A1c
3 secondary outcomes
Change from baseline in 2-hour postprandial glucose during standardized meal test
Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%
Proportion of patients achieving reduction in HbA1c of 0.5%
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 24 Feb 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nateglinide in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 1 site 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 5 inclusion and 14 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 24 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 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline in hemoglobin (Hb)_A1c. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2017.