MedDataX Logo

Combination of Glinides With Premixed Insulin

NCT ID: NCT00369148

Last Updated: 2009-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Insulin Glulisine in Type 2 Diabetic Patients

NCT00360698

Diabetes Mellitus, Type 2
COMPLETED PHASE4

Efficacy of Insulin Lispro Mix 50/50 Therapy

NCT01303042

Diabetes Mellitus, Type 2
UNKNOWN NA

Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

NCT00343980

Diabetes Diabetes Mellitus, Type 2
TERMINATED PHASE3

Insulin Schemes for Type 2 Diabetes Control

NCT03350984

Type 2 Diabetes Mellitus
COMPLETED PHASE4

Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes

NCT00191464

Diabetes Mellitus, Type 2
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabets Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nateglinide(drug) mitiglinide(drug)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of type 2 diabetes
* Who undergoes twice daily injection of premixed insulin
* Whose HbA1c is more than 6.5% and less than 8.0%

Exclusion Criteria

* Whose change of HbA1c is more than 1.0% during 12 weeks observational period
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Keio University

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Akira Shimada, MD, PhD

Role: STUDY_CHAIR

Keio University

Yoshihito Atsumi, MD

Role: STUDY_DIRECTOR

Saiseikai Central Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nippon Kokan Hospital

Kawasaki, Kanagawa, Japan

Site Status

Hamamatsu Red Cross Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Saiseikai Central Hospital

Minato-ku, Tokyo, Japan

Site Status

Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

Site Status

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

Tokyo Metropolitan Ohtsuka Hospital

Toshima-ku, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CS-NHK2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
NCT00642915 COMPLETED PHASE4
Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
NCT03359837 COMPLETED PHASE4
Insulin Glargine in Type 2 Diabetic Patients
NCT00347100 COMPLETED PHASE4
A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs
NCT02911948 COMPLETED PHASE3
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00395746 COMPLETED PHASE3
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00393718 COMPLETED PHASE3
Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
NCT02470039 COMPLETED PHASE2
Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes
NCT00469586 TERMINATED PHASE3
Insulin Glulisine in Diabetes Mellitus, Type 2
NCT00174668 COMPLETED PHASE3
Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
NCT01203111 COMPLETED PHASE4
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
NCT00358124 COMPLETED PHASE4
Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus
NCT01689142 COMPLETED PHASE3
Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
NCT01272193 COMPLETED PHASE3
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
NCT01269606 COMPLETED PHASE1
Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus
NCT00290927 COMPLETED PHASE3
The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine
NCT03659383 UNKNOWN PHASE4
Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers
NCT00969592 COMPLETED PHASE1
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
NCT00469092 COMPLETED PHASE4
Insulin Glulisine in Type 2 Diabetes Mellitus
NCT00310297 COMPLETED PHASE1
Low dosE GlibENclamide in Diabetes Part A
NCT02830048 COMPLETED PHASE2
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
NCT02680457 COMPLETED PHASE4
A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
NCT00570687 COMPLETED PHASE2
Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
NCT01121835 COMPLETED PHASE4
Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes
NCT00641407 COMPLETED PHASE4
Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes
NCT01536652 COMPLETED