Type-2 Diabetes MellitusPhase 4NCT01766778

Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

A Phase 4 study testing LAF237 (vildagliptin) and Metformin in people with Type-2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 4 sites in Hong Kong.

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

The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians \& patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type-2 Diabetes Mellitus
What is being tested?: LAF237 (vildagliptin) and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 4 sitesHong Kong
Study dates: 13 May 2013to 22 Oct 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or Female in age ≥18 at Visit 1
Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin

Who cannot join

Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1
Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
Pregnant women or breastfeeding women at the time of enrolment
Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment

Trial locations and contacts

4 sites in 1 country.

Hong Kong4 sites

Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Hong Kong
Novartis Investigative Site
Hong Kong SAR
Novartis Investigative Site
Tuenmen, Hong Kong

Other trials in Hong Kong

About this study

Official title: A Local Phase IV, Multicenter, Open-label Study to Evaluate Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

Conditions: Type-2 Diabetes Mellitus
Being tested: LAF237 (vildagliptin), Metformin
Keywords: type-2 diabetes mellitus, inadequately controlled Metformin

What participants receive

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

LAF237 (vildagliptin)Drug
Also called LAF237
Vildagliptin 50mg capsule
MetforminDrug
Metformin maximum tolerance dose

Study groups in NCT01766778
Study group	Role	What they receive
LAF237 (vildagliptin) 50mg once daily (QD)	Active comparator	Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin Receives: Drug: LAF237 (vildagliptin); Drug: Metformin
LAF237 (vildagliptin) 50mg twice daily (BID)	Active comparator	Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin Receives: Drug: LAF237 (vildagliptin); Drug: Metformin

What is being measured

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

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c
Measured: Baseline, Month 12 (weeK 52)

Secondary outcomes (5)

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.
Measured: Baseline, Month 3, 6, 9 and 12
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.
Measured: Baseline, Month 3, 6, 9 and 12
Percentage of Patients Achieving Good Glycemic Control
Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.
Measured: Month 3, 6, 9, 12
Percentage of Overall Drug Compliance in 12 Months
The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]
Measured: Month 12
Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability
This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported.
Measured: Month 12

Timeline

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

13 May 201322 Oct 2015

First posted11 Jan 2013 (estimated)
Study start13 May 2013
Primary completion22 Oct 2015
Study completion22 Oct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type-2 Diabetes MellitusStudies 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: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01766778
Sponsor's protocol ID: CLAF237AHK01
Status last verified: Apr 2017
First submitted: 9 Jan 2013
Last updated: 15 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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)

All Type-2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Local Phase IV, Multicenter, Open-label Study to Evaluate Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
ClinicalTrials.gov ID: NCT01766778
Acronym / sponsor ID: CLAF237AHK01
Conditions: Type-2 Diabetes Mellitus
Keywords: type-2 diabetes mellitus, inadequately controlled Metformin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 13 May 2013 (actual)
Primary completion: 22 Oct 2015 (actual)
Study completion: 22 Oct 2015 (actual)
First posted: 11 Jan 2013 (estimated)
Results: Posted 10 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LAF237 (vildagliptin) 50mg once daily (QD)	Active comparator	Drug: LAF237 (vildagliptin), Drug: MetforminVildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
LAF237 (vildagliptin) 50mg twice daily (BID)	Active comparator	Drug: LAF237 (vildagliptin), Drug: MetforminVildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or Female in age ≥18 at Visit 1
Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin

Key exclusion criteria (5 listed)

Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1
Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
Pregnant women or breastfeeding women at the time of enrolment
Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment

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
LAF237 (vildagliptin)Also: LAF237Vildagliptin 50mg capsule	Drug	LAF237 (vildagliptin) 50mg once daily (QD), LAF237 (vildagliptin) 50mg twice daily (BID)
MetforminMetformin maximum tolerance dose	Drug	LAF237 (vildagliptin) 50mg once daily (QD), LAF237 (vildagliptin) 50mg twice daily (BID)

Primary outcome

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
Time frame: Baseline, Month 12 (weeK 52)
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c

5 secondary outcomes

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
Time frame: Baseline, Month 3, 6, 9 and 12
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
Time frame: Baseline, Month 3, 6, 9 and 12
Percentage of Patients Achieving Good Glycemic Control
Time frame: Month 3, 6, 9, 12
Percentage of Overall Drug Compliance in 12 Months
Time frame: Month 12
Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability
Time frame: Month 12

Results and safety

Results posted to the registry on 10 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LAF237 (Vildagliptin) 50mg Once Daily (QD)	56	51
LAF237 (Vildagliptin) 50mg Twice Daily (BID)	61	57

Primary outcome: Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12

Time frame: Baseline, Month 12 (weeK 52). Mean (Standard Deviation). Unit: percentage of Glycosylated Hemoglobin

Measure	LAF237 (Vildagliptin) 50mg Once Daily (QD) n = 49	LAF237 (Vildagliptin) 50mg Twice Daily (BID) n = 50
Value	-0.8 (1.01)	-1.0 (1.24)

Population analysed: Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients with both baseline and 12 month data were included in this analysis

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAF237 (Vildagliptin) 50mg Once Daily (QD)	2 of 56 (3.6%)	14 of 56 (25%)	Not reported
LAF237 (Vildagliptin) 50mg Twice Daily (BID)	2 of 61 (3.3%)	7 of 61 (11.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type-2 Diabetes Mellitus

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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing LAF237 (vildagliptin) and Metformin in people with Type-2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 4 sites in Hong Kong.

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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Hong Kong. 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?

Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12 (time frame: Baseline, Month 12 (weeK 52)). 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 NCT01766778.

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 15 May 2017.