Trial Outcomes & Findings for A Clinical Study to Evaluate the Effect of Naturlose (Tagatose) (NCT NCT00961662)
NCT ID: NCT00961662
Last Updated: 2014-11-06
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
6 months from baseline
Results posted on
2014-11-06
Participant Flow
The study evaluated the data from 18 clinical study sites (11 sites in the United States and 7 sites in India)for approximately six months.
Clinical laboratory testing (including comprehensive hematology, clinical chemistry, liver function tests, lipid profile, HbA1c levels and urinalysis) was performed. A urine pregnancy test was performed for female subjects of childbearing potential.
Participant milestones
| Measure |
2.5 Active
Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
5.0 Mid Dose
5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
|
7.5 High Dose
high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
51
|
53
|
|
Overall Study
COMPLETED
|
35
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
22
|
19
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)
Baseline characteristics by cohort
| Measure |
2.5 Active
n=52 Participants
Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
5.0 Mid Dose
n=46 Participants
5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
|
7.5 High Dose
n=47 Participants
high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: ITT Population
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).
Outcome measures
| Measure |
2.5 Active
n=52 Participants
Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
5.0 Mid Dose
n=46 Participants
5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
|
7.5 High Dose
n=47 Participants
high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
|---|---|---|---|
|
Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus
|
10 participants
|
7 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
2.5 Active
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
5.0 Mid Dose
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
7.5 High Dose
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.5 Active
n=52 participants at risk
Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
5.0 Mid Dose
n=46 participants at risk
5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
|
7.5 High Dose
n=47 participants at risk
high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
|---|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
0.00%
0/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
2.1%
1/47 • Number of events 1 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
|
Nervous system disorders
Ataxia with Diabetic Neuropathy
|
0.00%
0/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
0.00%
0/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
2.1%
1/47 • Number of events 1 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
Other adverse events
| Measure |
2.5 Active
n=52 participants at risk
Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
5.0 Mid Dose
n=46 participants at risk
5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
|
7.5 High Dose
n=47 participants at risk
high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
44.2%
23/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
34.8%
16/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
36.2%
17/47 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
|
Infections and infestations
Infections and infestations
|
19.2%
10/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
15.2%
7/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
17.0%
8/47 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
|
General disorders
General disorders and administration site conditions
|
9.6%
5/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
10.9%
5/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
6.4%
3/47 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition disorders
|
5.8%
3/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
8.7%
4/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
10.6%
5/47 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
9.6%
5/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
6.5%
3/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
8.5%
4/47 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
|
Nervous system disorders
Nervous system disorder
|
9.6%
5/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
6.5%
3/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
6.4%
3/47 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders
|
1.9%
1/52 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
8.7%
4/46 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
0.00%
0/47 • 6 months
A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place