Type 2 DiabetesPhase 4NCT01309698

Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes

A Phase 4 study testing Vildagliptin (LAF237), Voglibose and Vildagliptin and Voglibose in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 1 site in Japan.

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

This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes. Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Vildagliptin (LAF237), Voglibose and Vildagliptin and Voglibose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteJapan
Study dates: Feb 2011to Apr 2011
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 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP)

Who cannot join

Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Japan1 site

Novartis Investigative Site
Tokyo

Other trials in Japan

About this study

Official title: An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes

This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: Vildagliptin (LAF237), Voglibose, Vildagliptin and Voglibose
Keywords: Drug interaction
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

Vildagliptin (LAF237)Drug
VogliboseDrug
Vildagliptin and VogliboseDrug

Study groups in NCT01309698
Study group	Role	What they receive
Treatment Sequence 1	Experimental	Not described Receives: Drug: Vildagliptin (LAF237); Drug: Voglibose; Drug: Vildagliptin and Voglibose
Treatment Sequence 2	Experimental	Not described Receives: Drug: Vildagliptin (LAF237); Drug: Voglibose; Drug: Vildagliptin and Voglibose
Treatment Sequence 3	Experimental	Not described Receives: Drug: Vildagliptin (LAF237); Drug: Voglibose; Drug: Vildagliptin and Voglibose
Treatment Sequence 4	Experimental	Not described Receives: Drug: Vildagliptin (LAF237); Drug: Voglibose; Drug: Vildagliptin and Voglibose
Treatment Sequence 5	Experimental	Not described Receives: Drug: Vildagliptin (LAF237); Drug: Voglibose; Drug: Vildagliptin and Voglibose
Treatment Sequence 6	Experimental	Not described Receives: Drug: Vildagliptin (LAF237); Drug: Voglibose; Drug: Vildagliptin and Voglibose

What is being measured

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

Pharmacokinetics of vildagliptin
Measured: Up to 12 hours post-dose

Secondary outcomes (1)

Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon)
Measured: Up to 4 hours or 12 hours post-dose

Timeline

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

Feb 2011Apr 2011

First posted7 Mar 2011 (estimated)
Study startFeb 2011
Primary completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01309698
Sponsor's protocol ID: CLAF237A1103
Status last verified: Nov 2016
First submitted: 4 Mar 2011
Last updated: 19 Dec 2020
Results posted: No

Publications

Yamaguchi M, Saji T, Mita S, Kulmatycki K, He YL, Furihata K, Sekiguchi K. Pharmacokinetic and pharmacodynamic interaction of vildagliptin and voglibose in Japanese patients with Type 2 diabetes. Int J Clin Pharmacol Ther. 2013 Aug;51(8):641-51. doi: 10.5414/CP201902.
PubMed 23782587

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

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01309698
Acronym / sponsor ID: CLAF237A1103
Conditions: Type 2 Diabetes
Keywords: Drug interaction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Apr 2011 (actual)
First posted: 7 Mar 2011 (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 evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment Sequence 1	Experimental	Drug: Vildagliptin (LAF237), Drug: Voglibose, Drug: Vildagliptin and Voglibose
Treatment Sequence 2	Experimental	Drug: Vildagliptin (LAF237), Drug: Voglibose, Drug: Vildagliptin and Voglibose
Treatment Sequence 3	Experimental	Drug: Vildagliptin (LAF237), Drug: Voglibose, Drug: Vildagliptin and Voglibose
Treatment Sequence 4	Experimental	Drug: Vildagliptin (LAF237), Drug: Voglibose, Drug: Vildagliptin and Voglibose
Treatment Sequence 5	Experimental	Drug: Vildagliptin (LAF237), Drug: Voglibose, Drug: Vildagliptin and Voglibose
Treatment Sequence 6	Experimental	Drug: Vildagliptin (LAF237), Drug: Voglibose, Drug: Vildagliptin and Voglibose

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP)

Key exclusion criteria (1 listed)

Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply

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
Vildagliptin (LAF237)	Drug	Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6
Voglibose	Drug	Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6
Vildagliptin and Voglibose	Drug	Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4, Treatment Sequence 5, Treatment Sequence 6

Primary outcome

Pharmacokinetics of vildagliptin
Time frame: Up to 12 hours post-dose

1 secondary outcome

Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon)
Time frame: Up to 4 hours or 12 hours post-dose

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 19 Dec 2020.
Results publication: PubMed 23782587Yamaguchi M, Saji T, Mita S, Kulmatycki K, He YL, Furihata K, Sekiguchi K. Pharmacokinetic and pharmacodynamic interaction of vildagliptin and voglibose in Japanese patients with Type 2 diabetes. Int J Clin Pharmacol Ther. 2013 Aug;51(8):641-51. doi: 10.5414/CP201902.
Results for CLAF237A1103 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.

Related trials for Type 2 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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 Vildagliptin (LAF237), Voglibose and Vildagliptin and Voglibose in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 1 site in Japan.

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 1 inclusion and 1 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 19 Dec 2020. 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 Japan. 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?

Pharmacokinetics of vildagliptin (time frame: Up to 12 hours post-dose). 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 NCT01309698, 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 19 Dec 2020.