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Diabetes MellitusPhase 4NCT00437918

The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients

A Phase 4 study testing nateglinide and acarbose in people with Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Inje University at 2 sites in South Korea.

Completed

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

Official record
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Trial summary

In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2 Diabetes Mellitus
What is being tested?
nateglinide and acarbose
How many people
85 participants
Where
2 sitesSouth Korea
Study dates
Jan 2007to Mar 2008
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Korean
  • Type 2 diabetes mellitus
  • No prior history of diabetic ketoacidosis
  • HbA1c between 7.5-10.0%

Who cannot join

  • Type 1 diabetes mellitus
  • Gestational diabetes mellitus
  • Secondary diabetes mellitus
  • Severe hyperglycemia with symptoms
  • Severe chronic diabetic complications (PDR,s-Cr>1.3mg/dL)

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University

    Busan, 614-735

  • Endocrinology and Metabolism, Maryknoll General Hospital

    Busan

Other trials in South Korea

About this study

Official title: Phase IV Study on Predictive Markers for the Effectiveness of Nateglinide or Acarbose for Controlling Post-Prandial Glucose in Type 2 Diabetics Already on Optimized Insulin Glargine Therapy

In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. Nateglinide and acarbose are frequently used for this purpose. We hypothesized that the short acting sulfonylurea "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. And we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.

Being tested
nateglinide, acarbose
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.

  • nateglinideDrug

  • acarboseDrug

What is being measured

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

  1. 7 point SMBG (self monitoring of blood glucose)

Secondary outcomes (1)

  1. HOMA-beta for predicting the effectiveness of each agents

Timeline

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

  1. First posted21 Feb 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2008
  4. Study completionMar 2008

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00437918
Sponsor's protocol ID
PDC-07-01
Status last verified
Mar 2008
First submitted
20 Feb 2007
Last updated
24 Mar 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim MK, Suk JH, Kwon MJ, Chung HS, Yoon CS, Jun HJ, Ko JH, Kim TK, Lee SH, Oh MK, Rhee BD, Park JH. Nateglinide and acarbose for postprandial glucose control after optimizing fasting glucose with insulin glargine in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jun;92(3):322-8. doi: 10.1016/j.diabres.2011.01.022. Epub 2011 Mar 3.

    PubMed 21376417

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nateglinide and acarbose in people with Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Inje University at 2 sites in South Korea.

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 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 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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 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?

7 point SMBG (self monitoring of blood glucose). 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 NCT00437918, which also lists 1 linked publication.

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 Mar 2008.

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