Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: D-Tagatose: 2.5/5.0/7.5 g TID for 6 months
Control Intervention1: NIL: NIL
Sponsors
Spherix Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of Type 2 Diabetes Mellitus in accordance to WHO criteria. 2.Gender: male and female patients. 3.Age: between 18 and 75 years of age. 4.Currently are not receiving any anti-diabetic medication within 3 months of the screening visit. Patients should be treated with diet and exercise only. 5.Have a HbA1c level at screening and baseline between 6.6% and 9.0%. Changes in HbA1c between screening and randomization visits cannot exceed 1.0% (if they do, a redraw will be done and if confirmed, the patient will have to be terminated from the study). 6.Fasting blood glucose concentration of less than 240 mg/dl (13.3 mmol/l). 7.BMI of less than or equal to 25 and greater than or equal to 45 kg/m2. 8.Weight stable (±10%) for 3 months before entry to study. 9.Are capable, as determined by the investigator, to the following: a. complete the study diary b. are receptive to diabetes education, including continuing their pre-study diet and activity levels c. are able to comply with the required study visits 10.Have given written informed consent to participate in this study in accordance to local regulations before any trial related activities (other than initial screening) are carried out.
Exclusion criteria
Exclusion criteria: 1.Have a current or recent history (within the prior 3 months) of treatment with any oral or injectable anti-diabetic treatment including sulfonylurea drugs (glimepiride glyburide, chlorpropamide, acetohexamide, glipizide, tolbutamide, tolazamide), thiazolidinediones (pioglitazone or roziglitazone), biguanides (metformin), alpha-glucosidase inhibitors (acarbose and miglitol), meglitinides (repaglinide), D-phenylalanine derivatives (nateglinide), dipeptidyl peptidase 4 (DPP-4) inhibitors (sitagliptin), insulin (lente, NPH, premixed, regular or ultralente), insulin-analogs (aspart, insulin glargine or lispro), exenetide, pramlintide or any other anti-diabetic medication. 2.Have had 1 or more episodes of severe hypoglycemia, as defined in the Abbreviations and Definitions section of this protocol, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness. 3.Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the last 6 months. 4.Are pregnant or plan to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. 5.Are women currently breastfeeding 6.Are currently or have recently (within the last 3 months) used any weight loss drugs for at least 14 consecutive days. 7.Have experienced any significant weight loss (less than or equal to 10% of their body weight) within the prior 3 months. 8.Suffer from any severe complications of Diabetes including diabetic retinopathy, neuropathy or nephropathy. 9.Currently suffer or have suffered within the last 6 months of a serious cardiac disease including decompensated congestive heart failure (NYHA class III or IV); unstable angina pectoris or a myocardial infarction. 10.Have a history of end stage renal disease (ESRD) or renal transplantation or are currently receiving renal dialysis. 11.Evidence of impaired renal function (serum creatinine 132 mM, or 1.5 mg/dL). 12.Have clinical signs or symptoms or laboratory evidence of severe liver disease (ALT and/or AST two times the upper limit of the reference range, as defined by the central reference laboratory) or have an albumin value above or below the normal reference range as defined by the central reference laboratory. 13.Presence of uncontrolled hypertension (systolic pressure 180 mm Hg and/or diastolic pressure 100 mm Hg) on two or more separate readings. 14.Documented organic gastrointestinal disease requiring treatment with medications likely to alter gut motility or absorption. 15.History of organ transplantation and are currently receiving treatment with immunosuppressive agents. 16.Patients diagnosed within the last five years of any malignancy (except for basal cell or squamous cell carcinoma of the skin) not yet treated or currently under treatment. 17.Have any of the following concomitant diseases: congenital or acquired immunodeficiency, clinically significant hematological, oncologic, renal, cardiac, hepatic, gastrointestinal or other serious disease, which in the judgment of the investigator could interfere with participation or retention into the study. 18.Have received a blood transfusion or severe blood loss within the last three months prior to enrollment or to suffe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of three low-doses of Naturlose (tagatose) in the glycemic control of patients with Type 2 Diabetes Mellitus as measured by HbA1c at the end of 6 months of therapy using the patients own baseline HbA1c levels as control.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| A decrease of Fasting Plasma Glucose (FPG) level compared with baseline level at any time point over the duration of the studyTimepoint: 6 months;A decrease of less than or equal to 0.5% in HbA1c level at each study visitTimepoint: 6 months;A decrease of less than or eual to 1% in HbA1c level in any of the Naturlose (tagatose) treatment groups at any time point over the duration of the studyTimepoint: 8 months;Body weight loss (compared to baseline)Timepoint: 6 months;Effects of Naturlose (tagatose) on other glycemic control measurements such as plasma glucose concentrations and plasma lipids at each study visitTimepoint: 6 months | — |
Countries
India, United States of America
Contacts
Public ContactPartha Chatterjee
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed