Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

NCT01582230 | Completed Phase 3

• 1 other identifier: CLAF237A23155
• Study Type: interventional
• Target: 293
• Locations: 4 countries
• Sites: 21

Brief Summary

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Vildagliptin

Outcome Measures

Primary Outcomes (2)

• Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population

  HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

  Baseline and every study visit up to 24 weeks

• Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population

  HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

  Baseline and every study visit up to 24 weeks

Secondary Outcomes (6)

• Number of patients with adverse events, serious adverse events and death on over all population

  24 weeks

• Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population

  Baseline, week 24

• Percentage of patients meeting responder criteria after 24 weeks treatment on overall population

  After 24 weeks

• Number of patients with adverse events, serious adverse events and death on Chinese population

  24 weeks

• Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population

  Baseline, week 24

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Drug: Vildagliptin

Placebo

PLACEBO COMPARATOR

Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Drug: Placebo

Interventions

Vildagliptin DRUG

Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks

Also known as: Galvus, LAF237

Vildagliptin

Placebo DRUG

Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
• C-peptide \>0.6 ng/ml (\>0.20 nmol/L).
• HbA1c ≥7.5 to ≤11% at Visit 1
• Treatment with stable, once or twice daily doses (maximum dose of \< 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
• Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
• Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit

You may not qualify if:

• Patients fulfilling any of the following criteria are not eligible for participation in the study
• Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
• Pregnant or lactating women
• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
• Current diagnosis of congestive heart failure (NYHA III or IV).
• Myocardial infarction (MI) within the past 6 months
• Liver disease such as cirrhosis or chronic active hepatitis

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (21)

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

Location

Novartis Investigative Site

Changsha, Hunan, 410003, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210006, China

Location

Novartis Investigative Site

Wuxi, Jiangsu, 214023, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110003, China

Location

Novartis Investigative Site

Jinan, Shandong, 250031, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710032, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610072, China

Location

Novartis Investigative Site

Beijing, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Tianjin, 300052, China

Location

Novartis Investigative Site

Pasay, Philippines, 1300, Philippines

Location

Novartis Investigative Site

Metro Manila, 1500, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Singapore, Singapore, 768825, Singapore

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Novartis Investigative Site

Bangkok, Bangkok, 10330, Thailand

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Ning G, Wang W, Li L, Ma J, Lv X, Yang M, Wang W, Woloschak M, Lukashevich V, Kothny W. Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. J Diabetes. 2016 May;8(3):345-53. doi: 10.1111/1753-0407.12303.

  PMID: 25929739 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

SG (2); TH (3); PH (3); CN (13)