Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled
      phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients
      with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be
      adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or
      pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD
      hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly
      controlled on their existing therapy. Preference for enrollment will be given to patients on
      insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic
      agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for
      the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking
      fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with
      intermediate-acting insulin may qualify for the study if both the patient and investigator
      are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the
      short acting insulin for at least 26 weeks. Patients treated with a sliding scale of
      short-acting insulin will not be eligible for enrollment.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled
      phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients
      with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be
      adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or
      pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD
      hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly
      controlled on their existing therapy. Preference for enrollment will be given to patients on
      insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic
      agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for
      the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking
      fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with
      intermediate-acting insulin may qualify for the study if both the patient and investigator
      are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the
      short acting insulin for at least 26 weeks. Patients treated with a sliding scale of
      short-acting insulin will not be eligible for enrollment.

      Following any insulin dose adjustment during the first few weeks of the study, insulin dose
      and regimen should remain constant for the duration of the study.

      No stand alone (e.g., other than pre-mixed) short- or ultrashort-acting insulin and/or
      sliding scale will be allowed for the entire duration of the study.

      A minimum of 400 patients will be randomized in this study (approximately 80 to each of the
      five treatment arms). Additional patients may be enrolled as appropriate to replace screen
      failures and drop-outs during the initial period of the study.
    

Intervention name(s): MBX-102; MBX-102; MBX-102; Placebo; Actos
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): MBX-102 200 mg once daily for 16 weeks; MBX-102 400 mg once daily for 16 weeks; MBX-102 600 mg once daily for 16 weeks; MBX-102 Placebo once daily for 16 weeks; Actos 30 mg once daily for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: insulin sensitizer; type 2 diabetes; diabetes; glucose control