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Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT01824264
Recruitment Status : Withdrawn
First Posted : April 4, 2013
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of the study is to evaluate the efficacy, tolerability and short-term safety of LIK066 to support dose selection for phase 3.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: LIK066 Drug: Sitagliptin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Evaluate Change in HbA1c After 12 Weeks Monotherapy With 7 Doses of LIK066 Compared With Placebo or Sitagliptin in Patients With Type 2 Diabetes
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LIK066 2.5 mg
Patients receive 2.5 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses

Experimental: LIK066 5 mg
Patients receive 5 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses

Experimental: LIK066 10 mg
Patients receive 10 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses

Experimental: LIK066 25 mg
Patients receive 25 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses

Experimental: LIK066 50 mg
Patients receive 50 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses

Experimental: LIK066 100 mg
Patients receive 100 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses

Experimental: LIK066 150 mg
Patients receive 150 mg of LIK066 once daily for 12 weeks
Drug: LIK066
Experimental treatment doses

Active Comparator: Sitagliptin 100 mg
Patients receive 100 mg sitagliptin once daily for 12 weeks
Drug: Sitagliptin
Active comparator treatment dose

Placebo Comparator: Placebo
Patients receive placebo for 12 weeks
Drug: Placebo
Placebo comparator dose




Primary Outcome Measures :
  1. Change from baseline in glycated hemoglobin (HbA1c) after 12 weeks [ Time Frame: baseline, 12 weeks ]
    Change from baseline in HbA1c after 12 weeks of treatment in each of the LIK066 doses and placebo


Secondary Outcome Measures :
  1. Change from baseline in Fasting Plasma Glucose [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on fasting plasma glucose after 12 weeks of treatment will be evaluated.

  2. Change from baseline in urinary glucose to creatinine ratio [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on urinary glucose to creatinine ratio after 12 weeks of treatment will be evaluated

  3. Change from baseline in Body weight [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on change in body weight after 12 weeks of treatment will be evaluated.

  4. Change from baseline in Blood pressure [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on change in systolic and diastolic blood pressure after 12 weeks of treatment will be evaluated.

  5. Change from baseline in postprandial glucose during a meal test [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on change in postprandial glucose during a meal test after 12 weeks of treatment will be evaluated.

  6. Change from baseline in beta cell function during a meal test [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on change in beta cell function during a meal test after 12 weeks of treatment will be evaluated.

  7. Change from baseline in insulin secretion relative to glucose during a meal test [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066on change in insulin secretion relative to glucose during a meal test after 12 weeks of treatment will be evaluated.

  8. Change from baseline in oral glucose insulin sensitivity during a meal test [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on change in oral glucose insulin sensitivity during a meal test after 12 weeks of treatment will be evaluated.

  9. Change from baseline in glucagon-like peptide response during a meal test [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on change in glucagon-like peptide during a meal test after 12 weeks of treatment will be evaluated.

  10. Change from baseline in Peptide YY response during a meal test [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on change in peptide YY response during a meal test after 12 weeks of treatment will be evaluated.

  11. Number of patients with adverse events to assess safety and tolerability of LIK066 [ Time Frame: 12 weeks ]
    The safety and tolerability of 7 doses of LIK066 after 12 weeks of treatment will be evaluated with number of patients reported for total adverse events, serious adverse events and death.

  12. Change from baseline in renal threshold for glucose excretion [ Time Frame: baseline, 12 weeks ]
    The effect of LIK066 on renal threshold for glucose excretion will be calculated from glucose values in an overnight urine collection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of T2DM by standard criteria
  2. Drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
  3. Currently untreated patients , who, after the diagnosis of T2DM, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to Visit 1
  4. Patients being treated with mono-therapy for at least 8 consecutive weeks prior to Visit 1 with the following OADs: metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), SU, glinide, alpha-glucosidase inhibitor (AGI)
  5. HbA1c ≥ 7 to ≤ 10.5% at Visit 1 for drug-naïve/currently untreated patients
  6. HbA1c ≥ 7 to ≤ 9.5% at Visit 1 for patients treated with OAD monotherapy
  7. HbA1c ≥ 7 to ≤ 10.5% at Visit 199 for ALL patients
  8. Age: ≥18 and ≤ 75 years old at Visit 1
  9. BMI ≥22 to ≤45 kg/m2 at Visit 1

Exclusion Criteria:

  1. FPG ≥270 mg/dl (15 mmol/L) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/L) for patients on OAD monotherapy at Visit 1
  2. Insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
  3. History of acute metabolic complications, CV disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
  4. Significant lab abnormalities such as TSH outside of normal range, UACR>300 mg/g creatinine, eGFR <60 ml/min/1.73m2, hemoglobin <12 g/L in men and <11 g/L in women, hematuria
  5. ECG abnormalities including AV block, long QT syndrome or QTc>450 msec for men and >470 msec for women
  6. History of malignancy
  7. Women of child-bearing potential not using effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824264


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01824264    
Other Study ID Numbers: CLIK066A2202
2012-005793-63 ( EudraCT Number )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 Diabetes mellitus, SGLT inhibitors, dose-response
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Licogliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors