Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

NCT02002221 | Completed Phase 4 Results

• 1 other identifier: CLAF237A1405
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 31

Brief Summary

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes Mellitus (DM) ,; diabetes,; noninsulin-dependent diabetes mellitus (NIDDM),; adult-onset diabetes,; high blood sugar,; T2DM

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups

  HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.

  Baseline, week 12

Secondary Outcomes (4)

• Percentage of Patients Meeting Responder Rates in HbA1c

  Baseline, week 12

• Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks

  Baseline, week 12

• Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia

  12 weeks

• Number of Participants With Adverse Events, Serious Adverse Events and Death

  12 weeks

Study Arms (2)

Vildagliptin (LAF237)

EXPERIMENTAL

Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Drug: Vildagliptin (LAF237); Drug: Insulin; Drug: Metformin

Placebo

PLACEBO COMPARATOR

In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Drug: Placebo; Drug: Insulin; Drug: Metformin

Interventions

Vildagliptin (LAF237) DRUG

Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily

Also known as: Vildagliptin

Vildagliptin (LAF237)

Placebo DRUG

Matching placebo of vildagliptin 50 mg twice daily

Placebo

Insulin DRUG

Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons. The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.

Placebo; Vildagliptin (LAF237)

Metformin DRUG

Patients continued their prescribed metformin dose, if applicable.

Placebo; Vildagliptin (LAF237)

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of T2DM by standard criteria.
• HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
• Age: ≥ 20 to \< 75 years old at Visit 1.
• BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

You may not qualify if:

• FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
• Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
• Significant heart diseases
• Hepatic disorder

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (31)

Novartis Investigative Site

Fukuoka, Fukuoka, 810-8798, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 815-0071, Japan

Location

Novartis Investigative Site

Fukutsu, Fukuoka, 811-3217, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 800-0295, Japan

Location

Novartis Investigative Site

Kōriyama, Fukushima, 963-8851, Japan

Location

Novartis Investigative Site

Mito, Ibaraki, 311-4153, Japan

Location

Novartis Investigative Site

Ibusuki, Kagoshima-ken, 891-0401, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 221-0802, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 861-8039, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 861-8520, Japan

Location

Novartis Investigative Site

Yatsushiro, Kumamoto, 866-8533, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 615-0035, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980-0021, Japan

Location

Novartis Investigative Site

Hirakata, Osaka, 573-0153, Japan

Location

Novartis Investigative Site

Izumisano, Osaka, 598-8577, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 530-0001, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 534-0021, Japan

Location

Novartis Investigative Site

Takatsuki, Osaka, 569-1096, Japan

Location

Novartis Investigative Site

Ageo, Saitama, 362-8588, Japan

Location

Novartis Investigative Site

Saitama, Saitama, 336-0963, Japan

Location

Novartis Investigative Site

Sayama, Saitama, 350-1305, Japan

Location

Novartis Investigative Site

Tokorozawa, Saitama, 359-1161, Japan

Location

Novartis Investigative Site

Adachi-ku, Tokyo, 123-0845, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 101-0024, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 103-0027, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 103-0028, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 104-0061, Japan

Location

Novartis Investigative Site

Nerima-ku, Tokyo, 177-0041, Japan

Location

Novartis Investigative Site

Nerima-ku, Tokyo, 177-0051, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 144-0051, Japan

Location

Novartis Investigative Site

Suginami-ku, Tokyo, 166-0004, Japan

Location

Related Publications (1)

• Hirose T, Suzuki M, Tsumiyama I. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study. Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 Nov 30.

  PMID: 26620049 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia

Interventions

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

Condition Hierarchy (Ancestors)

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; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 1, 2016
• Results First Posted: March 1, 2016

Record last verified: 2016-01

Locations

JP (31)