Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Vildagliptin; Drug: Insulin; Drug: Placebo

• Registration Number: NCT01862263
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-24
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

1. Informed consent read and signed before any protocol procedure.
2. Free will to sign the informed consent.
3. Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
4. Type 2 diabetes mellitus
5. Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
6. HbA1c between 7.5 to 9%.
7. Fasting plasma glucose (FPG) less than 270 mg/dL.
8. Body mass index (BMI) between 20 to 35 kg/m2.
9. Free willing to take the vildagliptin tablets during the study.

Exclusion Criteria

1. Pregnant or lactating female or without birth control method if of childbearing potential.
2. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
3. Acute cardiovascular complications or metabolic complications within the past 4 months.
4. History cerebrovascular disease during the last year.
5. History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
6. Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
7. Congestive heart failure requiring pharmacologic treatment.
8. Any known serious heart condition.
9. ALT and/or AST greater than three times the upper limit of the normal range.
10. Serum creatinine levels greater than 1.5 mg/dL
11. Malignancy including leukemia and lymphoma within the last 5 years

Other inlcusion/exclusion criteria may apply

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin	Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day
Vildagliptin	Insulin	Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day
Placebo	Placebo	Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)
Placebo	Insulin	Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)

Primary Outcome Measures

Name	Time	Method
Percentage of patients with hyperglycemic events evaluated with CGM	At 13 weeks	An hypoglycemic event is defined as any continuous glucose monitoring (CGM) measurement less than 60 mg/dL and a hyperglycemic is define as any CGM greater than 140 mg/dL.

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin	13 weeks
Number of hypoglycemia and/or hyperglycemia measured by CGM	13 weeks	An episode of hypoglycemia is defined as any value of glucose under 60 mg/dL, an episode of hyperglycemia is defined as any value of glucose above 140mg/dL measured by CGM.
Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day	0 to 24 hours daily for week 1, 4 and 13	Duration and intensity of hypoglycemic episodes, measured as area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day, measured by continuous glucose monitoring
Average of insulin units per day administered during the study	13 weeks	Change from baseline
Changes from the baseline in Lipid Profile	Baseline, 13 weeks	Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol
Change from baseline in Body weight	Baseline, 13 weeks	Weight will be measured on Kg.
Change from baseline in Blood pressure (BP),	Baseline, 13 weeks	BP will be mesured on mmHg
Change from baseline in Fasting plasma glucose (FPG),	Baseline, 13 weeks	FPG will be measured on mg/dL
Change from baseline in Hemoglobin A1C (HbA1c)	Baseline, 13 weeks	HbA1c will be measured on %
Change from baseline in Creatinine	Baseline, 13 weeks	Creatinine will be measured on mg/dL
Change from baseline in C-peptide	Baseline, 13 weeks	C-Peptide will be measured on microIU/mL
Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)	Baseline, 13 week	ALT/AST will be measured on ratio.
Changes from baseline in Direct bilirubin	Baseline, 13 weeks	Bilirubin will be measure on mg/dL
Changes from baseline in Body Mass Index (BMI)	Baseline, 13 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇲🇽 Puebla, Mexico