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Completed

NCT Number: NCT01871558

Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

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

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Antibes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Vildagliptin

Drug

50 mg b.i.d

Other names: Galvus

metformin

Drug

metformin is to be kept unchanged

sulfonylurea (SU)

Drug

Basal Insulin

Drug

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 24 weeks

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

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

    Time frame: Baseline, Week 24

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

    Time frame: Baseline, Week 24

  4. Mean Daily Insulin Dose at Week 24

    Time frame: Week 24

  5. Percentage of Patients With Severe and Confirmed Hypoglycemic Events

    Time frame: 24 weeks

    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

  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)

    Time frame: week 24

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: ADDONIS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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