A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

Phase 2

Withdrawn

Conditions: diabetes
Diabetes mellitus
10018424

Registration Number: NL-OMON40381

Lead Sponsor: Hanmi Pharmaceutical Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

1)Aged >= 18 and < 75 years at screening
2)Diagnosed with T2DM for at least 3 months prior to screening
3)Received diet and exercise therapy with or without metformin monotherapy for at least 3 months prior to screening; for subjects who have taken metformin monotherapy, the following minimum stable (i.e., at least 3 months on this dose) dose requirements apply:
a)>= 1500 mg/day of metformin or
b)maximum tolerated dose (the investigator must have documented the reason why up-titration to e.g., >= 1500 mg/day was not possible) or
c)maximum dose according to the country-specific label
4)HbA1c levels of between >= 7.0% and <= 10.0%, at screening
5)Body mass index (BMI) of < 40 kg/ m2 at screening
6)Females of child-bearing potential must test negative for serum pregnancy at screening and agree to use a highly effective method of birth control throughout the study and for at least 30 days after Visit 8/ET visit. Child-bearing potential is defined as women who have not been surgically sterilized 6 weeks prior to screening or are post-menopausal <= 1 year.
A highly effective method of birth control is considered to be one of the following:
-An oral or implanted hormonal method of contraception (if it has been used for >= 3 months prior to study drug administration) while also using a barrier method (i.e., a condom or a diaphragm);
-A hormone or copper intrauterine device if it has been in place for >= 3 months prior to study drug administration (subjects using a nonhormonal or copper intrauterine device should also use a barrier method [i.e., a condom or a diaphragm])
-A vasectomised partner
-Total abstinence is acceptable; however, the subject must use a highly effective method of contraception if the subject subsequently decides not to abstain.
7)Male subjects must agree to practice highly effective birth control methods during the conduct of the study and for at least 30 days after Visit 8/ET visit
8)Written informed consent must be obtained before any study-related assessment is performed

Exclusion Criteria

1)Pregnant or nursing (lactating) women
2)Diagnosis of type 1 diabetes mellitus
3)Uncontrolled diabetes defined as a fasting plasma glucose level of > 240 mg/dL (13.3 mmol/L) at screening
4)A significant change in body weight (at least ± 10%) in the 3 months before screening
5)The following medication exclusions apply:
a)Use of any concomitant medications at a dose that was not stable for the 3 months prior to randomisation, except as permitted below;
b)Use of a weight control treatment 3 months before screening, including any medication with a labelled reference to weight loss or weight gain and over-the-counter medications or herbal supplements;
c)Any antihyperglycaemic agents (including other incretin therapy such as dipeptidyl peptidase 4 inhibitors) other than metformin for > 2 weeks within the 3 months before screening or any use within 30 days of screening.;
d)Prior insulin use for a >= 3-month period at any time, use for > 2 weeks within 3 months before screening or any use within 30 days of screening;
e)Any previous treatment with a GLP-1 analogue ever including treatment in a clinical trial;
f)Any drugs that directly reduce gastrointestinal (GI) motility, including but not limited to chronic use of anticholinergics, antispasmodics, 5-hydroxytryptamine (5HT3) antagonists, dopamine antagonists or opiates within 4 weeks of screening;
g)Any daily medication with a history of causing upper GI AEs, such as bisphosphonates and high-dose acetylsalicylic acid (daily acetylsalicylic acid of 325 mg or less is allowed). Sites considering enrolling a patient on nonsteroidal anti-inflammatory drugs (NSAIDs) known to have a high incidence of GI side effects should contact the Medical Monitor before enrolling the patient;
h)Chronic anticoagulant therapy for any reason within 3 months before screening;
i)Current use of medications that prolong the QT interval/interval corrected by Fridericia formula (QTcF) (Section 13, Appendix 1)
j)Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives (of the used drug) of enrolment, whichever is longer
6)Known history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
7)Any history of GI intolerance (prolonged nausea and vomiting, chronic diarrhoea during the previous 6 months), gastric emptying abnormality, inflammatory bowel disease, partial bypass (ileal bypass) or gastric banding
8)Any previous GI bleeding or ulceration related to the use of NSAIDs within 3 months before screening
9)Subjects with severe heart or circulatory disease within 6 months prior to screening, defined as any one of the following:
a)Current symptomatic heart failure (New York Heart Association class III or IV) (NYHA 1994; Section 14, Appendix 2);
b)A myocardial infarction, coronary artery bypass graft surgery, or angioplasty within 6 months of screening;
c)Diagnosis of unstable angina requiring medication within 6 months of screening; or
d)Any transient ischemic attack, cerebral infarct, or cerebral haemorrhage within 6 months of screening
10)Poorly controlled hypertension (a resting systolic blood pressure [BP] > 160 mm Hg and/or diastolic BP > 100 mm Hg at screening)
11)Long QT syndrome or prolongation of QTcF interval (QTcF interval > 450 ms for males and > 470 ms for females) at screening
12)A history of additional risk factors for torsade de pointes (

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy parameter (HbA1c), as well as FPG, will be assessed at<br /><br>every visit during the dose-finding treatment period (Weeks 1, 2, 3, 5 and 9).<br /><br>The assessment to address the primary objective will be performed at Week 13<br /><br>(Day 85). Subjects will be instructed to assess their 7-point blood glucose<br /><br>profile every 4 weeks during the study, seven readings a day (before and 90<br /><br>minutes after each meal [breakfast, lunch, dinner] and at bedtime). The<br /><br>measurements will be averaged from two non-consecutive days during the week.<br /><br>Baseline measurement will be conducted on two consecutive or non-consecutive<br /><br>days between the dispensation of the glucometer to the subject and the baseline<br /><br>visit (Day 1) and averaged. Other secondary efficacy assessments will be<br /><br>scheduled at 4-weekly intervals. Safety assessments will be performed at all<br /><br>visits.</p><br>

Secondary Outcome Measures