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Type 2 Diabetes Mellitus (T2DM)Phase 3ADDONISNCT01871558

Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

A Phase 3 study testing Vildagliptin, Metformin and sulfonylurea (SU) in people with Type 2 Diabetes Mellitus (T2DM), run by Novartis Pharmaceuticals at 19 sites in France.

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

To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Vildagliptin, Metformin and sulfonylurea (SU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
19 sitesFrance
Study dates
Jun 2013to Feb 2015
Phase
Phase 3
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

  • T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken
  • with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization
  • with a glycemic target of HbA1c <= 7%
  • with HbA1c at inclusion >7% and <=9%
  • Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)

Who cannot join

  • contraindication for either SUs, metformin or insulin and history of hypersensitivity to vildagliptin
  • acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk
  • Other protocol defined inclusion/exclusion criteria may apply

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • Novartis Investigative Site

    Antibes, 06600

  • Novartis Investigative Site

    Auxerre, 89000

  • Novartis Investigative Site

    Bar-le-Duc, 55012

  • Novartis Investigative Site

    Bondy, 93143

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Caen, 14000

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Fleury-sur-Orne, 14123

  • Novartis Investigative Site

    Maisons-Laffitte, 78600

  • Novartis Investigative Site

    Menton, 06500

  • Novartis Investigative Site

    Montpellier, 34090

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Rennes, 35203

  • Novartis Investigative Site

    Saint-Nazaire, 44600

  • Novartis Investigative Site

    Sanary-sur-Mer, 83110

  • Novartis Investigative Site

    Strsbourg, 67000

  • Novartis Investigative Site

    Toulouse, 31300

  • Novartis Investigative Site

    Valence, 26000

  • Novartis Investigative Site

    Valenciennes, 59300

Other trials in France

About this study

Official title: Randomized, Open-label, SU-controlled Study of 24-week Duration to Compare Metformin/Vildagliptin + Basal Insulin Versus Metformin/SU + Basal Insulin in T2DM Patients Starting Basal Insulin After Failing Metformin/SU

To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.

Read the detailed description

This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.

Being tested
Vildagliptin, Metformin, sulfonylurea (SU), Basal Insulin
Keywords
type 2 diabetes, basal insulin, vildagliptin
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.

  • VildagliptinDrug

    Also called Galvus

    50 mg b.i.d

  • MetforminDrug

    metformin is to be kept unchanged

  • sulfonylurea (SU)Drug

  • Basal InsulinDrug

Study groups in NCT01871558
Study groupRoleWhat they receive
SU+metformin + Basal InsulinActive comparatorRandomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
Receives: Drug: Metformin; Drug: sulfonylurea (SU); Drug: Basal Insulin
Metformin/vildagliptin + Basal InsulinExperimentalRandomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
Receives: Drug: Vildagliptin; Drug: Metformin; Drug: Basal Insulin

What is being measured

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

  1. Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms

    Measured: 24 weeks

Secondary outcomes (6)

  1. Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events

    Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%

    Measured: 24 weeks

  2. Change From Baseline in HbA1c to Week 24 in Both Treatment Arms

    Measured: Baseline, Week 24

  3. Change From Baseline in Body Weight in Both Treatment Arms

    Measured: Baseline, Week 24

  4. Mean Daily Insulin Dose at Week 24

    Measured: Week 24

  5. Percentage of Patients With Severe and Confirmed Hypoglycemic Events

    Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) < 70 mg/dL

    Measured: 24 weeks

  6. Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline)

    HbA1c <= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain

    Measured: week 24

Timeline

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

  1. First posted6 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871558
Sponsor's protocol ID
CLAF237AFR07
Acronym
ADDONIS
Status last verified
Mar 2016
First submitted
4 Jun 2013
Last updated
21 Apr 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vildagliptin, Metformin and sulfonylurea (SU) in people with Type 2 Diabetes Mellitus (T2DM), run by Novartis Pharmaceuticals at 19 sites in France.

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 3 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Mar 2016). 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?

Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms (time frame: 24 weeks). 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 NCT01871558.

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 21 Apr 2016.

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