Phase 2 N=375 Randomized Double-blind Treatment

A New Oral Treatment For Type II Diabetes Mellitus

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT00111800 ↗

Enrolled (actual)

375

Serious AEs

2.9%

Results posted

Mar 2018

Primary outcome: Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 — 0.46; 0.18; -0.07; 0.01 Percentage of HbA1c — p=0.061

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); DEN 2.5 mg (Drug); DEN 7.5 mg (Drug); DEN 15 mg (Drug); DEN 30 mg (Drug); DEN 45 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jul 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	0.46; 0.18; -0.07; 0.01; -0.34; -0.38	0.061
SECONDARY Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24	0.22; -0.01; -0.11; -0.05; -0.25; -0.32	—
SECONDARY Change From Baseline in FPG at Week 12	0.52; 0.11; -0.28; -0.07; -0.95; -0.71	0.306
SECONDARY Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24	0.33; 0.18; -0.45; -0.11; -0.73; -0.71	—
SECONDARY Number of Participants Who Were HbA1c Responders at Week 12	6; 4; 4; 5; 9; 8	0.909
SECONDARY Number of Participants of FPG Responders at Week 12	5; 8; 9; 4; 6; 9	0.380
SECONDARY Change From Baseline in Fructosamine at Week 12	19.9; 5.0; -2.5; -9.3; -19.7; -19.0	0.057
SECONDARY Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24	10.3; -4.3; -2.9; -10.1; -14.8; -22.0	—
SECONDARY Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12	-2.04; -10.55; 12.14; 5.27; 3.23; 10.70	0.489
SECONDARY Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8	5.97; -3.83; 2.85; 1.67; 21.80; 7.23	—
SECONDARY Change From Baseline in Pro-insulin at Week 16, 20 and 24.	-2.32; -4.45; -3.27; -4.24; -4.67; -1.35	—
SECONDARY Change From Baseline in Pro-insulin to Insulin Ratio at Week 12	-0.02; 0.01; -0.04; -0.06; -0.08; -0.06	0.286
SECONDARY Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8	-0.02; -0.03; -0.03; -0.07; -0.13; -0.05	—
SECONDARY Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia	28; 26; 31; 36; 29; 30	—
SECONDARY Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe	16; 7; 21; 14; 9; 14	—
SECONDARY Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy	4; 4; 1; 5; 4; 6	—
SECONDARY Change From Baseline in Body Weight Over Time	1.09; 0.94; 0.52; 0.53; 1.24; 0.63	—
SECONDARY Change From Baseline in Body Mass Index (BMI) Over Time	0.374; 0.392; 0.183; 0.207; 0.538; 0.239	—
SECONDARY Change From Baseline in Waist Circumference and Hip Circumference Over Time	-0.1; 0.0; -0.5; -0.3; 0.6; -0.2	—
SECONDARY Mean Change From Baseline in Waist to Hip Ratio Over Time	0.01; 0.02; 0.01; 0.01; -0.02; 0.01	—
SECONDARY Change From Baseline in 12-lead ECG Over Time	-1.5; 1.0; 0.3; -0.1; -1.3; 0.4	—
SECONDARY Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy	0; 0; 0; 0; 1; 1	—
SECONDARY Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy	3; 0; 2; 0; 2; 2	—
SECONDARY Number of Participants With Abnormal Urinalysis Dipstick Result	7; 3; 6; 4; 3; 9	—
SECONDARY Number of Participants With Urinalysis Microscopic Result	3; 1; 2; 0; 2; 2	—
SECONDARY Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN	—	—
SECONDARY Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK	—	—

Summary

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Eligibility Criteria

Inclusion criteria

Women must not be pregnant and must not be breastfeeding.
Have Type II diabetes.
Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria

Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00111800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.