Diabetes Mellitus, Type 2Phase 1/2PREVENT-SIHNCT07757464
Pre-emptive Insulin to Prevent High Glucose After a Knee Steroid Injection in Adults With Type 2 Diabetes
A Phase 1/2 study testing Insulin Isophane Human, NPH, Pre-emptive Algorithm and Triamcinolone Acetonide Knee Injection in people with Diabetes Mellitus, Type 2 and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
Steroid injections used to treat painful joints can temporarily increase glucose levels in people with type 2 diabetes. This study will test whether a short course of pre-emptive neutral protamine Hagedorn, NPH, insulin can reduce high glucose after a standard corticosteroid injection into the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia Due to Type 2 Diabetes Mellitus, Osteoarthritis, Knee
- What is being tested?
- Insulin Isophane Human, NPH, Pre-emptive Algorithm and Triamcinolone Acetonide Knee Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2026to 30 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 80 years at consent.
- Documented diagnosis of type 2 diabetes for at least 6 months.
- HbA1c from 6.5% through 9.0% measured within 30 days before randomisation.
- Symptomatic osteoarthritis of one knee for which the treating clinician has independently determined that an intra-articular corticosteroid injection is clinically indicated.
- Planned administration of one intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg into the index knee.
- Diabetes managed without insulin, sulfonylureas or meglitinides.
Show all 11Show fewer
- Permitted glucose-lowering medications at stable doses for at least 30 days before randomisation.
- Estimated glomerular filtration rate at least 45 mL/min/1.73 m² within 60 days before randomisation.
- Capillary glucose from 90 through 250 mg/dL immediately before the injection.
- Ability and willingness to perform scheduled capillary glucose testing, administer or receive subcutaneous insulin if assigned, follow hypoglycaemia instructions and remain contactable through day 7.
- Ability to wear the study continuous glucose monitoring device and provide informed consent.
Who cannot join
- Type 1 diabetes, latent autoimmune diabetes in adults, pancreatogenic diabetes or another specific diabetes type requiring insulin.
- Current basal, prandial, premixed or pump insulin treatment.
- Current sulfonylurea or meglitinide treatment.
- HbA1c below 6.5% or above 9.0%.
- Capillary glucose below 90 mg/dL or above 250 mg/dL immediately before injection.
- Fasting glucose above 250 mg/dL, random glucose above 300 mg/dL, clinically significant ketonaemia or hyperglycaemia requiring immediate treatment during screening.
Show all 21Show fewer
- Estimated glomerular filtration rate below 45 mL/min/1.73 m².
- Severe hepatic impairment or another condition expected to materially alter insulin clearance or hypoglycaemia risk.
- Level 3 hypoglycaemia requiring third-party assistance during the previous 6 months.
- Documented impaired awareness of hypoglycaemia.
- Pregnancy, planned pregnancy during study participation or breastfeeding.
- Oral, intravenous or intramuscular corticosteroid use within 30 days before the study injection.
- Any intra-articular, epidural, periarticular or soft-tissue corticosteroid injection within 30 days before the study injection.
- Planned additional systemic or injected corticosteroid exposure before the day-7 assessment.
- Acute febrile illness, active systemic infection or acute deterioration in health at screening or injection.
- Suspected septic arthritis, infection over the injection site, prosthetic index knee, uncontrolled bleeding disorder or another contraindication to knee injection.
- Known allergy or clinically significant hypersensitivity to triamcinolone acetonide, human NPH insulin, insulin aspart, protamine, lidocaine or required excipients.
- Known allergy to continuous glucose monitoring adhesive or a skin condition preventing sensor use.
- Cognitive, visual, physical or social limitation that would prevent safe glucose testing, insulin administration, hypoglycaemia treatment or study contact.
- Participation in another interventional study likely to affect glucose or corticosteroid response.
- Any condition that, in the investigator's documented judgement, makes participation unsafe for a reason not otherwise captured above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Randomized Trial of Pre-emptive NPH Insulin Versus Usual Reactive Diabetes Management for Preventing Hyperglycaemia After Intra-articular Triamcinolone Acetonide Injection in Adults With Type 2 Diabetes and Knee Osteoarthritis
Steroid injections used to treat painful joints can temporarily increase glucose levels in people with type 2 diabetes. This study will test whether a short course of pre-emptive neutral protamine Hagedorn, NPH, insulin can reduce high glucose after a standard corticosteroid injection into the knee.
Adults with type 2 diabetes who are scheduled to receive one intra-articular injection of triamcinolone acetonide 40 mg for knee osteoarthritis will be randomly assigned to one of two groups. The experimental group will receive a prespecified NPH insulin regimen beginning immediately after the injection and continuing for three doses. The comparison group will continue usual reactive diabetes management without pre-emptive NPH insulin.
Both groups will use blinded continuous glucose monitoring and scheduled capillary glucose testing. The main outcome is the percentage of continuous glucose monitoring time above 180 mg/dL during the first 72 hours after the corticosteroid injection. Hypoglycaemia, rescue treatment, healthcare contacts, treatment burden, acceptability and adverse events will also be assessed.
Read the detailed description
Intra-articular corticosteroid injections can produce clinically important but transient hyperglycaemia in people with type 2 diabetes. Published studies have largely characterised this glucose response rather than testing a standardised strategy to prevent it.
PREVENT-SIH is a phase 2, randomised, parallel-group trial in adults with type 2 diabetes managed without insulin or insulin secretagogues. All participants will receive a clinically indicated, standardised intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg into one index knee for symptomatic knee osteoarthritis.
Participants will be randomly assigned 1:1 to a pre-emptive NPH insulin pathway or usual reactive diabetes management. The pre-emptive pathway comprises three weight-based NPH doses starting immediately after the corticosteroid injection, with prespecified glucose-based dose modification, withholding and discontinuation rules. Both groups will continue stable background diabetes medication and will receive identical blinded continuous glucose monitoring, capillary glucose monitoring, safety instructions, scheduled contacts and rescue thresholds.
Continuous glucose monitoring data will be collected for a 72-hour baseline period and for at least 96 hours after injection. The primary analysis will compare the percentage of valid readings above 180 mg/dL during the first 72 hours after injection, adjusted for baseline continuous glucose monitoring time above 180 mg/dL, site and HbA1c stratum. Rescue treatment and other post-randomisation diabetes treatment changes will be retained in the primary treatment-policy analysis.
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia Due to Type 2 Diabetes Mellitus, Osteoarthritis, Knee
- Being tested
- Insulin Isophane Human, NPH, Pre-emptive Algorithm, Triamcinolone Acetonide Knee Injection
- Keywords
- Steroid-induced hyperglycaemia, Glucocorticoid-induced hyperglycaemia, Intra-articular corticosteroid injection, Triamcinolone acetonide, NPH insulin, Continuous glucose monitoring, Knee osteoarthritis
- Medical subject headings
- Diabetes Mellitus, Type 2, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Isophane Human, NPH, Pre-emptive AlgorithmDrug
Also called Human NPH Insulin, Neutral Protamine Hagedorn Insulin
Human NPH insulin U-100 will be administered subcutaneously within 30 minutes after the knee injection at 0.10 units/kg actual body weight, rounded to the nearest whole unit, maximum 16 units. Doses are repeated approximately 24 and 48 hours later. For doses 2 and 3, predose glucose below 90 mg/dL requires withholding; 90 to 109 mg/dL requires 50% of the initial dose; 110 to 180 mg/dL requires 100%; 181 to 250 mg/dL requires 120%; and above 250 mg/dL requires 120%, maximum 20 units, plus clinician contact. Any glucose below 54 mg/dL or level 3 hypoglycaemia permanently discontinues study NPH.
Triamcinolone Acetonide Knee InjectionDrug
Also called Triamcinolone Acetonide Crystalline Suspension
A single 1 mL intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg/mL, total dose 40 mg, will be administered into one index knee using a standardised landmark-guided procedure. Up to 2 mL lidocaine 1% without epinephrine may be used for skin and subcutaneous anaesthesia but will not be mixed with or injected into the joint. No repeat or additional injected corticosteroid is permitted through day 7.
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive NPH Insulin Pathway | Experimental | Participants will receive three subcutaneous doses of human NPH insulin beginning within 30 minutes after intra-articular triamcinolone acetonide injection and repeated approximately 24 and 48 hours later. The initial dose is 0.10 units/kg, maximum 16 units. Subsequent doses are modified according to prespecified capillary-glucose and hypoglycaemia criteria. Participants will continue stable background diabetes medication and receive blinded continuous glucose monitoring, scheduled capillary glucose testing, safety contacts and the common rescue pathway. Receives: Drug: Insulin Isophane Human, NPH, Pre-emptive Algorithm |
| Usual Reactive Diabetes Management | Active comparator | Participants will continue stable background diabetes medication without pre-emptive NPH insulin. They will receive blinded continuous glucose monitoring, the same scheduled capillary glucose testing, safety instructions, study contacts and common rescue pathway as the experimental group. Additional non-emergency medication changes may be made by the treating diabetes clinician when clinically necessary and will be documented. Receives: Drug: Triamcinolone Acetonide Knee Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Continuous Glucose Monitoring Time Above 180 mg/dL During the First 72 Hours After Corticosteroid Injection
The numerator is the number of valid continuous glucose monitoring readings above 180 mg/dL from the recorded completion time of the intra-articular injection through exactly 72 hours. The denominator is the total number of valid readings during that window. The result is expressed as a percentage. A directly observed outcome requires at least 80% of expected readings and no uninterrupted data gap longer than 6 hours. Participants not meeting this requirement have a missing primary outcome for statistical handling; missing readings are not counted as being within or above range.
Measured: From completion of the intra-articular corticosteroid injection through 72 hours after injection
Secondary outcomes (12)
Percentage of Continuous Glucose Monitoring Time Above 250 mg/dL
Number of valid continuous glucose monitoring readings above 250 mg/dL divided by all valid readings, multiplied by 100. The primary-outcome valid-data requirements apply.
Measured: From completion of the injection through 72 hours after injection
Continuous Glucose Monitoring Area Under the Curve Above 180 mg/dL
Incremental area above 180 mg/dL calculated using the trapezoidal rule across adjacent valid readings separated by no more than 30 minutes. The observed mean excess above 180 mg/dL is standardised to a 72-hour period and reported in mg/dL-hours.
Measured: From completion of the injection through 72 hours after injection
Mean Sensor Glucose
Arithmetic mean of all valid continuous glucose monitoring readings during the assessment window, reported in mg/dL.
Measured: From completion of the injection through 72 hours after injection
Peak Sensor Glucose
Highest valid continuous glucose monitoring glucose value during the assessment window, reported in mg/dL.
Measured: From completion of the injection through 72 hours after injection
Time to Peak Sensor Glucose
Elapsed time in hours from completion of the injection to the first occurrence of the participant's peak valid sensor glucose.
Measured: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time in Range, 70 to 180 mg/dL
Number of valid continuous glucose monitoring readings from 70 through 180 mg/dL divided by all valid readings, multiplied by 100.
Measured: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time Below 70 mg/dL
Number of valid continuous glucose monitoring readings below 70 mg/dL divided by all valid readings, multiplied by 100.
Measured: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time Below 54 mg/dL
Number of valid continuous glucose monitoring readings below 54 mg/dL divided by all valid readings, multiplied by 100.
Measured: From completion of the injection through 72 hours after injection
Participants With Clinically Significant Hypoglycaemia
Number and percentage of participants with capillary glucose below 54 mg/dL, continuous glucose monitoring glucose below 54 mg/dL lasting at least 15 consecutive minutes, or level 3 hypoglycaemia requiring third-party assistance.
Measured: From completion of the injection through day 7
Participants Requiring Rescue Glucose-Lowering Treatment
Number and percentage of participants receiving protocol rescue insulin or any additional glucose-lowering medication initiated for post-injection hyperglycaemia.
Measured: From completion of the injection through 72 hours after injection
Number of Unscheduled Diabetes-Related Clinical Contacts or Healthcare Encounters
Count per participant of unscheduled telephone calls, electronic contacts, clinic visits, urgent-care visits or emergency-department encounters primarily related to glucose management.
Measured: From completion of the injection through day 7
Participant-Reported Treatment Burden Score
Study-specific numerical rating from 0 to 10, where 0 means no treatment burden and 10 means extreme treatment burden.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start10 Aug 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Al Ain University
- Responsible party
- Principal investigator, Saima Abass Tahammal, Shifa International Hospital
- Investigators
- Saima Abbass, MD, PhD, Study director, Shifa hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757464
- Sponsor's protocol ID
- SH-67214349
- Other IDs
- SIAC-02812
- Acronym
- PREVENT-SIH
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the principal published results may be made available together with a data dictionary, study protocol, statistical analysis plan and analytic code. Data sharing will be subject to applicable ethics approval, participant consent, institutional policy and protection against participant reidentification. Data that cannot be adequately deidentified will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Trial of Pre-emptive NPH Insulin Versus Usual Reactive Diabetes Management for Preventing Hyperglycaemia After Intra-articular Triamcinolone Acetonide Injection in Adults With Type 2 Diabetes and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07757464
- Acronym / sponsor ID
- PREVENT-SIH / SH-67214349
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia Due to Type 2 Diabetes Mellitus, Osteoarthritis, Knee
- Keywords
- Steroid-induced hyperglycaemia, Glucocorticoid-induced hyperglycaemia, Intra-articular corticosteroid injection, Triamcinolone acetonide, NPH insulin, Continuous glucose monitoring, Knee osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Collaborators
- Al Ain University
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Steroid injections used to treat painful joints can temporarily increase glucose levels in people with type 2 diabetes. This study will test whether a short course of pre-emptive neutral protamine Hagedorn, NPH, insulin can reduce high glucose after a standard corticosteroid injection into the knee.
Adults with type 2 diabetes who are scheduled to receive one intra-articular injection of triamcinolone acetonide 40 mg for knee osteoarthritis will be randomly assigned to one of two groups. The experimental group will receive a prespecified NPH insulin regimen beginning immediately after the injection and continuing for three doses. The comparison group will continue usual reactive diabetes management without pre-emptive NPH insulin.
Both groups will use blinded continuous glucose monitoring and scheduled capillary glucose testing. The main outcome is the percentage of continuous glucose monitoring time above 180 mg/dL during the first 72 hours after the corticosteroid injection. Hypoglycaemia, rescue treatment, healthcare contacts, treatment burden, acceptability and adverse events will also be assessed.
Detailed description
Intra-articular corticosteroid injections can produce clinically important but transient hyperglycaemia in people with type 2 diabetes. Published studies have largely characterised this glucose response rather than testing a standardised strategy to prevent it.
PREVENT-SIH is a phase 2, randomised, parallel-group trial in adults with type 2 diabetes managed without insulin or insulin secretagogues. All participants will receive a clinically indicated, standardised intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg into one index knee for symptomatic knee osteoarthritis.
Participants will be randomly assigned 1:1 to a pre-emptive NPH insulin pathway or usual reactive diabetes management. The pre-emptive pathway comprises three weight-based NPH doses starting immediately after the corticosteroid injection, with prespecified glucose-based dose modification, withholding and discontinuation rules. Both groups will continue stable background diabetes medication and will receive identical blinded continuous glucose monitoring, capillary glucose monitoring, safety instructions, scheduled contacts and rescue thresholds.
Continuous glucose monitoring data will be collected for a 72-hour baseline period and for at least 96 hours after injection. The primary analysis will compare the percentage of valid readings above 180 mg/dL during the first 72 hours after injection, adjusted for baseline continuous glucose monitoring time above 180 mg/dL, site and HbA1c stratum. Rescue treatment and other post-randomisation diabetes treatment changes will be retained in the primary treatment-policy analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive NPH Insulin Pathway | Experimental | Drug: Insulin Isophane Human, NPH, Pre-emptive AlgorithmParticipants will receive three subcutaneous doses of human NPH insulin beginning within 30 minutes after intra-articular triamcinolone acetonide injection and repeated approximately 24 and 48 hours later. The initial dose is 0.10 units/kg, maximum 16 units. Subsequent doses are modified according to prespecified capillary-glucose and hypoglycaemia criteria. Participants will continue stable background diabetes medication and receive blinded continuous glucose monitoring, scheduled capillary glucose testing, safety contacts and the common rescue pathway. |
| Usual Reactive Diabetes Management | Active comparator | Drug: Triamcinolone Acetonide Knee InjectionParticipants will continue stable background diabetes medication without pre-emptive NPH insulin. They will receive blinded continuous glucose monitoring, the same scheduled capillary glucose testing, safety instructions, study contacts and common rescue pathway as the experimental group. Additional non-emergency medication changes may be made by the treating diabetes clinician when clinically necessary and will be documented. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 40 to 80 years at consent.
- Documented diagnosis of type 2 diabetes for at least 6 months.
- HbA1c from 6.5% through 9.0% measured within 30 days before randomisation.
- Symptomatic osteoarthritis of one knee for which the treating clinician has independently determined that an intra-articular corticosteroid injection is clinically indicated.
- Planned administration of one intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg into the index knee.
Key exclusion criteria (21 listed)
- Type 1 diabetes, latent autoimmune diabetes in adults, pancreatogenic diabetes or another specific diabetes type requiring insulin.
- Current basal, prandial, premixed or pump insulin treatment.
- Current sulfonylurea or meglitinide treatment.
- HbA1c below 6.5% or above 9.0%.
- Capillary glucose below 90 mg/dL or above 250 mg/dL immediately before injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Isophane Human, NPH, Pre-emptive AlgorithmAlso: Human NPH Insulin, Neutral Protamine Hagedorn InsulinHuman NPH insulin U-100 will be administered subcutaneously within 30 minutes after the knee injection at 0.10 units/kg actual body weight, rounded to the nearest whole unit, maximum 16 units. Doses are repeated approximately 24 and 48 hours later. For doses 2 and 3, predose glucose below 90 mg/dL requires withholding; 90 to 109 mg/dL requires 50% of the initial dose; 110 to 180 mg/dL requires 100%; 181 to 250 mg/dL requires 120%; and above 250 mg/dL requires 120%, maximum 20 units, plus clinician contact. Any glucose below 54 mg/dL or level 3 hypoglycaemia permanently discontinues study NPH. | Drug | Pre-emptive NPH Insulin Pathway |
| Triamcinolone Acetonide Knee InjectionAlso: Triamcinolone Acetonide Crystalline SuspensionA single 1 mL intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg/mL, total dose 40 mg, will be administered into one index knee using a standardised landmark-guided procedure. Up to 2 mL lidocaine 1% without epinephrine may be used for skin and subcutaneous anaesthesia but will not be mixed with or injected into the joint. No repeat or additional injected corticosteroid is permitted through day 7. | Drug | Usual Reactive Diabetes Management |
Primary outcome
Percentage of Continuous Glucose Monitoring Time Above 180 mg/dL During the First 72 Hours After Corticosteroid Injection
Time frame: From completion of the intra-articular corticosteroid injection through 72 hours after injection
The numerator is the number of valid continuous glucose monitoring readings above 180 mg/dL from the recorded completion time of the intra-articular injection through exactly 72 hours. The denominator is the total number of valid readings during that window. The result is expressed as a percentage. A directly observed outcome requires at least 80% of expected readings and no uninterrupted data gap longer than 6 hours. Participants not meeting this requirement have a missing primary outcome for statistical handling; missing readings are not counted as being within or above range.
12 secondary outcomes
Percentage of Continuous Glucose Monitoring Time Above 250 mg/dL
Time frame: From completion of the injection through 72 hours after injection
Continuous Glucose Monitoring Area Under the Curve Above 180 mg/dL
Time frame: From completion of the injection through 72 hours after injection
Mean Sensor Glucose
Time frame: From completion of the injection through 72 hours after injection
Peak Sensor Glucose
Time frame: From completion of the injection through 72 hours after injection
Time to Peak Sensor Glucose
Time frame: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time in Range, 70 to 180 mg/dL
Time frame: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time Below 70 mg/dL
Time frame: From completion of the injection through 72 hours after injection
Percentage of Continuous Glucose Monitoring Time Below 54 mg/dL
Time frame: From completion of the injection through 72 hours after injection
Participants With Clinically Significant Hypoglycaemia
Time frame: From completion of the injection through day 7
Participants Requiring Rescue Glucose-Lowering Treatment
Time frame: From completion of the injection through 72 hours after injection
Number of Unscheduled Diabetes-Related Clinical Contacts or Healthcare Encounters
Time frame: From completion of the injection through day 7
Participant-Reported Treatment Burden Score
Time frame: Day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the principal published results may be made available together with a data dictionary, study protocol, statistical analysis plan and analytic code. Data sharing will be subject to applicable ethics approval, participant consent, institutional policy and protection against participant reidentification. Data that cannot be adequately deidentified will not be shared.
Related trials for Diabetes Mellitus, Type 2
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saima Abbass, MD, PhD study director
Shifa hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Insulin Isophane Human, NPH, Pre-emptive Algorithm and Triamcinolone Acetonide Knee Injection in people with Diabetes Mellitus, Type 2 and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Continuous Glucose Monitoring Time Above 180 mg/dL During the First 72 Hours After Corticosteroid Injection (time frame: From completion of the intra-articular corticosteroid injection through 72 hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.