Trial Outcomes & Findings for Naturlose (D-Tagatose) Efficacy Evaluation Trial (NCT NCT00955747)

Last Updated: 2014-11-19

Results Overview

The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

494 participants

Primary outcome timeframe

1 year from baseline

Results posted on

2014-11-19

Participant Flow

Patients were recruited in site physicians' offices.

Patients participated in an eight week run-in period during which diabetes education was provided and diet and exercise were stabilized.

Participant milestones

Participant milestones
Measure	Sugar Substitute Splenda 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.	Tagatose 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
Overall Study STARTED	253	241
Overall Study COMPLETED	184	172
Overall Study NOT COMPLETED	69	69

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Naturlose (D-Tagatose) Efficacy Evaluation Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Substitute Splenda n=184 Participants 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.	Tagatose n=172 Participants 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment	Total n=356 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	160 Participants n=5 Participants	152 Participants n=7 Participants	312 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Age, Continuous	51.6 years STANDARD_DEVIATION 11.0 • n=5 Participants	51.7 years STANDARD_DEVIATION 9.7 • n=7 Participants	51.7 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	91 Participants n=7 Participants	186 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	81 Participants n=7 Participants	170 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	52 participants n=7 Participants	100 participants n=5 Participants
Region of Enrollment India	136 participants n=5 Participants	120 participants n=7 Participants	256 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year from baseline

Population: Calculation of the final numbers for study completion considers a standard deviation of 1.4%, a two-sided 95% confidence interval (alpha= 0.025), power of 90%, and the ability to detect a 0.5% difference in HbA1c between treatment and placebo groups.

Outcome measures

Outcome measures
Measure	Sugar Substitute Splenda n=184 Participants 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.	Tagatose n=172 Participants 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
Change in Hemoglobin A1C Level From Baseline	0.09 percentage of change from baseline Standard Error 0.07	-0.11 percentage of change from baseline Standard Error 0.07

Adverse Events

Sugar Substitute Splenda

Serious events: 8 serious events

Other events: 166 other events

Deaths: 0 deaths

Tagatose

Serious events: 4 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugar Substitute Splenda n=207 participants at risk 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.	Tagatose n=185 participants at risk 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
Cardiac disorders atrial fibrillation, cardiac chest pain, shortness of breath,	1.4% 3/207 • Number of events 3 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	1.1% 2/185 • Number of events 2 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Respiratory, thoracic and mediastinal disorders Pneumonia, lower respiratory infection	0.97% 2/207 • Number of events 2 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	0.00% 0/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Musculoskeletal and connective tissue disorders Asthenia	0.00% 0/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	0.54% 1/185 • Number of events 1 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Musculoskeletal and connective tissue disorders Worsening of Lower Backache	0.48% 1/207 • Number of events 1 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	0.00% 0/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma Head of Pancreas	0.48% 1/207 • Number of events 1 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	0.00% 0/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	0.54% 1/185 • Number of events 1 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Loose stools	0.48% 1/207 • Number of events 1 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	0.00% 0/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Borborygmus	0.48% 1/207 • Number of events 1 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	0.00% 0/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.

Other adverse events

Additional Information

Robert Lodder

University of Kentucky

Phone: 859-955-0845

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sugar Substitute Splenda n=207 participants at risk 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.	Tagatose n=185 participants at risk 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
Gastrointestinal disorders abdominal pain	16.9% 35/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	29.7% 55/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Abdominal Distension	13.5% 28/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	27.6% 51/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Gastrointestinal motility disorder	14.5% 30/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	24.3% 45/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Dyspepsia	14.5% 30/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	22.2% 41/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Infrequent bowel movements	12.6% 26/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	19.5% 36/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Vomiting	11.6% 24/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	18.4% 34/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Gastroesophageal reflux disease	10.6% 22/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	18.4% 34/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Faeces hard	11.6% 24/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	15.1% 28/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Nervous system disorders Headache	11.1% 23/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	11.9% 22/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Epigastric discomfort	7.7% 16/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	14.1% 26/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Infections and infestations Pyrexia	8.7% 18/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	9.2% 17/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Renal and urinary disorders Urinary Tract Infection	5.8% 12/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	9.7% 18/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Blood and lymphatic system disorders Dyslipidaemia	6.8% 14/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	7.6% 14/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	5.8% 12/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	4.3% 8/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Infections and infestations Upper respiratory tract infection	5.8% 12/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	4.9% 9/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 11/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	3.2% 6/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Musculoskeletal and connective tissue disorders Back pain	5.3% 11/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	2.2% 4/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Diarrhoea	24.6% 51/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	64.9% 120/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Flatulence	22.7% 47/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	45.9% 85/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Gastrointestinal sounds abnormal	18.4% 38/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	50.3% 93/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Frequent bowel movements	11.6% 24/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	35.7% 66/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Eructation	17.4% 36/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	27.6% 51/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
Gastrointestinal disorders Defaecation urgency	12.1% 25/207 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.	34.6% 64/185 • One year Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.