A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)

NCT00961662 | Completed Phase 2 Results

• 1 other identifier: 70971-005
• Study Type: interventional
• Target: 161
• Locations: 2 countries
• Sites: 13

Brief Summary

This study is a six-month, prospective, randomized, multicenter, single- blind, controlled clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic control and safety in subjects with Type 2 diabetes under diet control and exercise. The subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus

  The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).

  6 months from baseline

Secondary Outcomes (5)

• Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit

  6 months

• A Decrease of ≥0.5% in HbA1c Level at Each Study Visit

  6 months

• A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study

  8 months

• A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study

  6 months

• Body Weight Loss (Compared to Baseline)

  6 months

Study Arms (3)

2.5 active

EXPERIMENTAL

2.5 Active - 2.5 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.

Drug: D-Tagatose

5.0 mid dose

ACTIVE COMPARATOR

5.0 mid dose - 5.0 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.

Drug: D-Tagatose

7.5 high dose

ACTIVE COMPARATOR

7.5 high dose - 7.5 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.

Drug: D-Tagatose

Interventions

D-Tagatose DRUG

powder to be dissolved in water prior to dosage.

Also known as: Naturlose

2.5 active; 5.0 mid dose; 7.5 high dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetics in accordance with WHO.
• Male and female patients, between 18 and 75 years of age.
• Diabetic patients who are not on medication for the disease. Patients may be treated with diet and exercise.
• Normal blood creatine clearance and normal liver function test results.
• BMI less than or equal to 45 kg/m2

You may not qualify if:

• Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide, Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta, insulin, and any antidiabetic medications within the prior 3 months.
• Therapy with beta-blockers or thiazide diuretics within the prior 3 months
• Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure.
• Documented gastrointestinal disease, or taking of medications likely to alter gut motility or absorption.
• Receiving any investigational drug within 30 days of the baseline visit.

Sponsors & Collaborators

• Robert Lodder: lead
• University of Kentucky: collaborator

Study Sites (13)

Probe Clinical Research Corp.

Garden Grove, California, 92843, United States

Location

Pharmax Research Clinic

Miami, Florida, 33126, United States

Location

PMI Health Research Group

Atlanta, Georgia, 30312, United States

Location

Ialim Clinical Research Center

Decatur, Georgia, 30035, United States

Location

Juno Research, LLC

Houston, Texas, 77036, United States

Location

Diabetes Care and Research Centre

Patna, Bihar, 800 020, India

Location

Bharti Research Institute of Diabetes and Endocrinology

Karnāl, Haryana, 132 001, India

Location

Bangalore Endocrinology and Diabetes Research Centre

Bangalore, Karnataka, 560 003, India

Location

Medisys Clinisearch India Pvt. Ltd.

Bangalore, Karnataka, 560 043, India

Location

Belgaum Diabetes Centre

Belagavi, Karnataka, 590 001, India

Location

Krishna Diabetes Clinic and Educational Research Centre

Bhopal, Madhya Pradesh, 462 003, India

Location

Diabetes Thyroid Hormone Research Institute Pvt. Ltd

Indore, Madhya Pradesh, 452 001, India

Location

Research Health Institute in Diabetes Endocrinology and Metabolism

Mumbai, Maharashtra, 400 014, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tagatose

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robert Lodder
• Organization: University of Kentucky

lodder@uky.edu

859-955-0845

Study Officials

• Robert Lodder

  University of Kentucky

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 19, 2009
• Study Start: February 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 6, 2014
• Results First Posted: November 6, 2014

Record last verified: 2014-11

Locations

US (5); IN (8)