Using two drugs in combination at the start of drug treatment for type 2 diabetes vs using a single drug

Intensified treatment at the onset of diagnosis of type 2 diabetes mellitus in drug naive patients in the asian population

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26805203

Enrollment

285

Registered

2017-05-11

Start date

2010-01-19

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Participants are randomised to one of six groups using covariate adaptive randomization. 1. MHD2 Group: Metformin 1000mg twice daily 2. MHD255 Group: Metformin 850mg thrice daily 3. SMHD Group: (Sita

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients with type 2 diabetes 2. Had not receievd any prior medication for diabetes 3. Aged 18 – 80 years 4. Asian ethnicity (Pakistani population)

Exclusion criteria

Exclusion criteria: 1. Previous history of ischaemic heart disease 2. Previous history of stroke or other cerebrovascular disease 3. Previous history of chronic kidney disease

Design outcomes

Primary

Measure	Time frame
Glycated Haemoglobin is measured at baseline, 3, 6, 9, and 18 months, 2, 3, and 5 years using a standardized laboratory assay for HbA1c. The reduction in HbA1c is calculated by subtracting the former measurements from the latter.	—

Secondary

Measure	Time frame
1. Percentage of patients achieving and maintaining the target HbA1c of <7% is assessed from the documented HbA1c measured at baseline, 3, 6, 9, and 18 months, 2, 3, and 5 years 2. Need for additional therapy is assessed by the treating physician based on the laboratory parameters highlighted above and was documented on the patients file along with the choice of the add on agent at any point within the study period 3. Hypoglycaemia, if suspected, is checked by the patient using a glucometer and the recording reading was documented in mg/dL at any point within the study period 4. Weight is measured using a digital weighing scale at the clinic at baseline, 3, 6, 9, and 18 months, 2, 3, and 5 years	—

Measure

Time frame

1. Percentage of patients achieving and maintaining the target HbA1c of <7% is assessed from the documented HbA1c measured at baseline, 3, 6, 9, and 18 months, 2, 3, and 5 years 2. Need for additional therapy is assessed by the treating physician based on the laboratory parameters highlighted above and was documented on the patients file along with the choice of the add on agent at any point within the study period 3. Hypoglycaemia, if suspected, is checked by the patient using a glucometer and the recording reading was documented in mg/dL at any point within the study period 4. Weight is measured using a digital weighing scale at the clinic at baseline, 3, 6, 9, and 18 months, 2, 3, and 5 years

—

Countries

Pakistan

Contacts

Public ContactMohammad Ali Arif

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026