---
title: Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes
nct_id: NCT00383578
overall_status: COMPLETED
phase: PHASE3
sponsor: Novartis Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Diabetes Mellitus, Type 2
countries: Germany, Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00383578.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00383578"
ct_last_update_post_date: 2020-12-17
last_seen_at: "2026-05-12T07:33:40.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

**Official Title:** A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes

**NCT ID:** [NCT00383578](https://clinicaltrials.gov/study/NCT00383578)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 335
- **Lead Sponsor:** Novartis Pharmaceuticals
- **Conditions:** Diabetes Mellitus, Type 2
- **Start Date:** 2006-09
- **CT.gov Last Update:** 2020-12-17

## Brief Summary

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

## Eligibility

- **Minimum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age from 65 years to the upper age limit recommended by local prescribing information for metformin
* Drug naive patients with type 2 diabetes.
* Body mass index (BMI) in the range of 22-40 kg/m2.
* HbA1c in the range of 7 to 9% inclusive
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents

Other protocol-defined inclusion/exclusion criteria may apply
```

## Arms

- **Vildagliptin** (EXPERIMENTAL)
- **Metformin** (ACTIVE_COMPARATOR)

## Interventions

- **Vildagliptin 100 mg qd** (DRUG)
- **Metformin 1500 mg daily** (DRUG)

## Primary Outcomes

- **Change from baseline in HbA1c** _(time frame: after 24 weeks of treatment)_

## Secondary Outcomes

- **Adverse event profile** _(time frame: after 24 weeks of treatment)_
- **Gastrointestinal tolerability** _(time frame: after 24 weeks of treatment)_
- **Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%** _(time frame: after 24 weeks of treatment)_
- **Change from baseline in fasting plasma glucose** _(time frame: after 24 weeks of treatment)_
- **Change from baseline in body weight** _(time frame: after 24 weeks of treatment)_

## Locations (2)

- Investigative Centers, Nuremberg, Germany
- Novartis Pharmaceuticals, Basel, Switzerland

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.investigative centers|nuremberg||germany` — added _(2026-05-12)_
- `locations.novartis pharmaceuticals|basel||switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00383578.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00383578*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*