NCT01188200

Brief Summary

The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
Last Updated

August 25, 2010

Status Verified

July 1, 2010

Enrollment Period

6 months

First QC Date

August 24, 2010

Last Update Submit

August 24, 2010

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • The primary variable is glucose concentration

    0 to 240 minutes

Secondary Outcomes (1)

  • Additional measures of glucose concentration

    0 to 240 mins

Study Arms (2)

Nutritional Formula #M979

EXPERIMENTAL

nutritional formula

Other: Experimental nutritional formula #M979

Regular standard meal

ACTIVE COMPARATOR

standard meal

Other: Standard food

Interventions

Experimental nutritional formula #M979OTHER

One two hundred and forty mL serving at test time, taken orally

Nutritional Formula #M979
Standard foodOTHER

Standard meal prior to test time

Regular standard meal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has type 2 diabetes.
  • Subject is over 18 years of age.
  • Subject is a male, or a non-pregnant, non-lactating female.
  • Subject's BMI is \> 20 kg/m2 and \< 40 kg/m2.
  • Subject's HbA1c level is 6.5 - 11%.
  • If on a chronic thyroid medication or hormone replacement therapy, subject has been on constant dosage for at least two months prior to Screening Visit.
  • Subject's weight is stable for the past two months prior to Screening Visit.

You may not qualify if:

  • Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control.
  • Subject has type 1 diabetes.
  • Subject has history of diabetic ketoacidosis.
  • Subject has the following: current infection ; has had inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or antibiotics in the last 3 weeks prior to screening.
  • Subject has an active malignancy.
  • Subject has had significant cardiovascular event \<6 months prior to study entry or history of congestive heart failure.
  • Subject has end stage organ failure.
  • Subject has history of severe gastroparesis, renal or hepatic disease.
  • Subject has an active metabolic, hepatic, or gastrointestinal disease or condition that may interfere with nutrient absorption, distribution, metabolism, or excretion, excluding diabetes.
  • Subject has a chronic, contagious, infectious disease.
  • Taking daily medications at doses that would interfere with nutrient absorption, metabolism, excretion, gastric motility, or blood glucose.
  • Subject has fainted or experienced other adverse event in response to blood collection prior to enrollment into this study.
  • Clotting or bleeding disorders.
  • Allergic or intolerant to any ingredient found in the test meal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Kuban State Medical University

Krasnodar, 350043, Russia

Location

City Clinical Hospital #68

Moscow, 109263, Russia

Location

City Clinical Hospital #52

Moscow, 123182, Russia

Location

City Hospital #67

Moscow, 123423, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630047, Russia

Location

State Novosibirsk Regional Hospital

Novosibirsk, 630087, Russia

Location

City Clinical Hospital #3

Saint Petersburg, 195257, Russia

Location

Medical Centre Twenty First Century

Saint Petersburgh, 190068, Russia

Location

Diabetes Centre, LLC

Samara, 443046, Russia

Location

Tyumen State Medical Academy

Tyumen, 625023, Russia

Location

Bashkir State Medical University

Ufa, 450071, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anne Voss, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 25, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 25, 2010

Record last verified: 2010-07

Locations

RU(11)